Category: Advantages of Conducting Trials in Latin America

Figures cited from the live ClinicalTrials.gov record NCT07147192 and the published bioaccess® Dominican Republic and El Salvador country pages, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current DIGEMAPS, CONABIOS, and FDA rules with qualified advisers. Instituto Espaillat Cabral is distinct from Laser Center / Batlle GORE listings. bioaccess® is not listed on the NCT and no bioaccess® page claims this Alcon study. “Alcon Investigator 8071” is not used as a clinic name.

If you searched Instituto Espaillat Cabral clinical trial, Espaillat Cabral IOL, Alcon accommodating IOL Santo Domingo, or “go direct to Espaillat,” you followed a facility name ClinicalTrials.gov published. Instituto Espaillat Cabral in Santo Domingo is a real ophthalmic site. It is not the operator of the DIGEMAPS file.

bioaccess®’s position is simple and it is not adversarial: Espaillat Cabral is the site. The First-in-Human CRO still owns DIGEMAPS / CONABIOS, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus El Salvador, Panama, Costa Rica, or Colombia if one Santo Domingo room is not the design. Sponsors who skip the CRO and email the institute still have to rebuild that stack.

This page does not clone clinical trials in the Dominican Republic. That page stays the country system. This page answers the site-named query. It is not a Laser Center intercept.

What NCT07147192 actually says for Santo Domingo

NCT07147192 — Feasibility Study of an Accommodating IOL Design. Sponsor: Alcon Research. Organization study ID: ILK345-E001. Overall status: RECRUITING. The Espaillat row is NOT_YET_RECRUITING. Actual start 3 December 2025; estimated completion January 2028; estimated enrollment 85; device-feasibility, contralateral AAL-FAIOL vs BAL-FAIOL after phacoemulsification, 14–35 days between eyes, ~1 year follow-up, optional laser adjustment of the AAL lens. Conducted in Central America per the brief summary (the location table also includes the Dominican Republic). Primary outcome: cumulative ocular adverse events including secondary surgical interventions. Ages 22+. Central contact: Alcon Call Center. Study director: Clinical Trial Lead, Surgical, Alcon Research, LLC. No local PI is named on the Espaillat row.

Sister rows on the same live record: Clinica 20/20, San José, Costa Rica (RECRUITING); Centro Panamericano de Ojos / Clinica Lopez Beltran, San Salvador (NOT_YET_RECRUITING); Panama Eye Center, Panama City (RECRUITING). See the López Beltrán intercept for the San Salvador twin. Panama Eye Center is publicly identified in MINIject literature as formerly Clínica de Ojos Orillac-Calvo; NCT03193736 lists that Panama City name for STAR-I (COMPLETED). Those are public-record facts, not bioaccess® case studies.

Distinct from Laser Center

Santo Domingo has more than one ophthalmic brand in device-trial search results. This intercept is only Instituto Espaillat Cabral as written on NCT07147192. We searched CMS for a Laser Center slug before writing; it was not occupied as a dedicated intercept. We will not merge Espaillat Cabral with Laser Center, CODET, or a Batlle GORE study. If a later wave publishes those buildings, they will get their own pages.

The institute is a site. The CRO is the operator.

Espaillat Cabral can provide cataract rooms and surgeons who can, when activated, implant an investigational accommodating IOL. That is necessary. It is not sufficient for a four-country feasibility file a U.S. board expects to survive FDA review.

• DIGEMAPS. The Ministry of Public Health’s Directorate General of Medicines, Food and Health Products is the national authority on the published DR country page. A clinic letter is not that dossier.
• CONABIOS / REC. Published clocks: institutional REC ~30 days; CONABIOS-level ~45 days, up to 120 depending on complexity. Someone still has to write the packet.
• Investigational import into the Dominican Republic — importer of record.
• ISO 14155 monitoring that also covers sister rows in El Salvador, Panama, and Costa Rica.
• 21 CFR 812.28 — eligibility, not clearance. OUS FIH and FDA IDE.

Site versus CRO

Workstream	What Espaillat Cabral typically owns	What the CRO still owns
Cataract / accommodating IOL capability	OR, biometry, implanting ophthalmologists	Protocol feasibility, training, AAL-FAIOL / BAL-FAIOL accountability
Ethics	Institutional REC coordination	CONABIOS-overseen packet, ICF, IB alignment
National authority	Not a hallway conversation	DIGEMAPS
Import	Receiving dock if contracted	Importer of record
Quality	Clinic quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative
Country optionality	One Santo Domingo row, currently not yet recruiting	Panama, El Salvador, Costa Rica, Colombia if the design needs them

DIGEMAPS in one screen

Published on clinical-trials-dominican-republic: DIGEMAPS as national authority; CONABIOS-overseen RECs; Helsinki / CIOMS; 21 CFR 812.28 eligibility with ISO 14155; nearshore U.S. flights; experience-based ~30% lower program cost versus a U.S./EU baseline on that page. Those are country figures, not an Espaillat quote.

El Salvador’s published 30–60 day parallel SRS / CNEIS clock and Panama’s published MINSA / CNBI pathway sit on their country pages if the same Alcon design is the reason you are also looking at San Salvador or Panama City.

Four NCT rows, one operator problem

ILK345-E001 is already a multi-country design. Costa Rica and Panama are recruiting on the live record; Santo Domingo and San Salvador are not. Emailing Espaillat Cabral does not activate Panama Eye Center, Clinica 20/20, or López Beltrán, and it does not file DIGEMAPS, SRS, or MINSA. If the honest next case is in a country that is already recruiting, that is a CRO sequencing decision — not a reason to smear the Dominican site for being listed as not yet recruiting. The row is a fact. The file is still the CRO’s.

What “not yet recruiting” is not

NOT_YET_RECRUITING on a Santo Domingo row is not a quality judgment and not a reason to attack the institute. It means Alcon’s public file has not flipped that location to recruiting. A CRO still has to file DIGEMAPS, clear CONABIOS-overseen ethics, import the lenses, train the team, and monitor to ISO 14155 before that flip is operationally real. Treating the NCT status as the entire startup plan is how boards lose a quarter.

Colombia is still on the map

bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A Santo Domingo NCT row is not an instruction to abandon INVIMA. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Frequently asked questions

Can I contract Instituto Espaillat Cabral directly?

You can try. The institute can discuss interest and local cataract costs. It cannot become your DIGEMAPS applicant, importer, insurer, ISO 14155 monitor, or 812.28 packager because Alcon listed it. The Santo Domingo row is still not yet recruiting. Contract the CRO; let the CRO activate the site or a sister country already recruiting.

Did bioaccess® run ILK345-E001 at Espaillat?

No public bioaccess® page says so. We will not invent that claim.

Is this the Laser Center / Batlle study?

No. This page is only Instituto Espaillat Cabral on NCT07147192. Do not merge the buildings.

Is this first-in-human?

The record’s primary purpose is DEVICE_FEASIBILITY. That is the honest label.

If I already have the institute name, what does the CRO still do?

Regulatory-fit across the NCT countries plus Colombia; DIGEMAPS / CONABIOS; insurance; import; activation; ISO 14155; 812.28.

Does googling Espaillat mean I should avoid the institute?

No. Do not smear the site. The error is treating the site as the CRO.

Next step

Contact bioaccess® · First-in-Human CRO · Dominican Republic · CT.gov hub · López Beltrán · Quesada · CRO in Colombia.

Figures cited from live ClinicalTrials.gov records NCT00233792 and NCT06688448 and the published bioaccess® Brazil country page, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the institute and trials those records support. The 1999–2005 sirolimus FIM is historic — we say so. bioaccess® is not listed on either NCT and no bioaccess® page claims these studies.

If you searched Dante Pazzanese first-in-man, Instituto Dante Pazzanese clinical trial, sirolimus stent Brazil FIM, or “go direct to Pazzanese,” you followed a facility name ClinicalTrials.gov published. Instituto Dante Pazzanese de Cardiologia in São Paulo is a real tertiary cardiology site. It is not the operator of today’s ANVISA file.

bioaccess®’s position is simple and it is not adversarial: Dante Pazzanese is the site. The First-in-Human CRO still owns ANVISA / CEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus Colombia if INVIMA is the better next file. Sponsors who skip the CRO and email the institute still have to rebuild that stack. A historic first-in-man plaque does not make the hospital a CRO.

This page does not clone clinical trials in Brazil. That page stays the country system. This page answers the institute-named query.

What the public NCT file actually says

NCT00233792 — brief title: FIM-BR – First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent. Official title: evaluation of the sirolimus-coated modified BX VELOCITY balloon-expandable stent in de novo or restenotic native coronary lesions. Lead sponsor: Cordis US Corp. Status: COMPLETED. Start listed December 1999; actual completion March 2005; actual enrollment 30; phases 1 and 2; single-center, non-randomized; interventions: sirolimus-coated Bx VELOCITY, fast-release and slow-release, on the Raptor OTW delivery system; repeat angiography at four months; twelve-month follow-up. Facility: Instituto Dante Pazzanese of Cardiology, São Paulo, Brazil. Principal investigator on the record: Eduardo J Sousa, MD. This is a genuine historic first-in-man program. It is also more than twenty years old. Treat it as history, not as a 2026 startup clock.

NCT06688448 — VANGUARD, “Valvular Assessment of New Generation Aortic Replacement Devices.” Official title: comparative efficacy and durability of next-generation biological aortic prostheses. Lead sponsor: Instituto Dante Pazzanese de Cardiologia (other/academic). Status: RECRUITING. Actual start 1 December 2024; estimated completion 1 December 2036; estimated enrollment 200; ages 18–65; randomized, open-label, parallel, single-center AVR. Interventions: Dafodil® prosthesis and INSPIRIS Resilia® (the record also writes “Inspires Resilia”). Primary outcome: rate of bioprosthetic valve deterioration. The detailed description states the trial is conducted at a tertiary cardiology hospital of the Brazilian Unified Health System (SUS); Fundação Adib Jatene is named as a resource; device supply is supported by Meril Life Sciences and Edwards Lifesciences. Location: Instituto Dante Pazzanese de Cardiologia, São Paulo, RECRUITING, with named contacts Tacianne Rolemberg Delamain and Patrícia Paiva / Patricia Paiva. This is a hospital-sponsored comparison of two commercial-generation bioprostheses. It is not a first-in-human of an unapproved startup valve, and we will not market it as one.

Neither record names bioaccess®. That is how a sponsor finds Dante Pazzanese without finding the operator for a new investigational device.

Historic FIM is not today’s operator layer

Eduardo Sousa’s sirolimus FIM is part of interventional cardiology’s public memory. It is fair to say the institute has run first-in-man coronary work. It is not fair to tell a 2026 board that “Pazzanese already knows how to file ANVISA, import an investigational TMVR, monitor to ISO 14155, and package 21 CFR 812.28 because they did a Cordis stent in 1999.” Those workstreams have been rewritten — RDC 837/2023, Law 14874, importer-of-record practice, and FDA’s foreign-data rule among them.

VANGUARD shows the other trap: a recruiting, hospital-sponsored surgical-valve RCT can look like “the hospital is already running devices.” It is running its comparison of Dafodil and INSPIRIS inside SUS. Your unapproved device is a different contract, a different dossier, and usually a different import.

Site versus CRO

Workstream	What Dante Pazzanese typically owns	What the CRO still owns
Cardiac capability	Cath lab, OR, imaging, implanting physicians, SUS tertiary infrastructure	Protocol feasibility, training, investigational-device accountability
Ethics	Institutional CEP calendar	Packet, ICF, IB alignment
National authority	Not a hallway conversation, even after a famous FIM	ANVISA RDC 837/2023 dossier when the study is a clinical investigation of your device
Import	Receiving dock if contracted	Importer of record — LATAM import page
Quality	Hospital quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance. OUS FIH and FDA IDE
Country optionality	One São Paulo institute	InCor, Einstein, Colombia, Panama if the indication needs them

ANVISA in one screen

Published on the Brazil country page: ethics + ANVISA typically 6–10 weeks; CEP review capped at 30 business days under Law 14874; per-patient $20,000–$35,000; 15+ pre-qualified sites; trial authorization ≠ RDC 751/2022 market registration. Those are country figures, not a Pazzanese quote.

Do not confuse three São Paulo cardiology brands

InCor (HCFMUSP) is the Cephea / Leaflex facility. Hospital Israelita Albert Einstein is the sponsor of an UNKNOWN robotic-PCI record. Dante Pazzanese is the historic Cordis FIM institute and the VANGUARD AVR site. They are all in São Paulo and they are not interchangeable. A sponsor who emails “the São Paulo heart hospital” has not selected a site. bioaccess®’s job is to pick the room after the regulatory-fit review — and to keep Colombia on the table when INVIMA is the cleaner file — not to flatten three NCT brands into one hallway.

We will also not assign PercAssist, PAVmed, ReGelTec, or Mitralign to Dante Pazzanese. Those names remain country-level or unsourced at hospital level on the press hub.

Colombia is still on the map

bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A 1999 São Paulo FIM is not a reason to leave INVIMA. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Frequently asked questions

Can I contract Dante Pazzanese directly?

You can try. The institute can discuss investigator interest, CEP calendars, and procedure costs. It cannot become your ANVISA applicant, importer, insurer, ISO 14155 monitor, or 812.28 packager because Cordis ran a FIM there a generation ago. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the sirolimus FIM or VANGUARD?

No. We will not invent that claim. Named bioaccess® hospital-level FIH remains on the Panama Clinic, Santa Fe, and Asunción intercepts and their source case-study pages.

Is VANGUARD first-in-human?

Not as labeled. It is a recruiting randomized comparison of two named bioprostheses, hospital-sponsored, with industry device supply. Use it as evidence the institute is active in surgical valves — not as your startup’s FIH template.

If I already have the institute name, what does the CRO still do?

Regulatory-fit; ANVISA / CEP; insurance; import; activation; ISO 14155; 812.28; the option to use InCor or a Colombian site instead of or besides Pazzanese.

Does googling the historic FIM mean I should avoid the institute?

No. Do not smear Dante Pazzanese. The error is treating a 1999–2005 first-in-man as the 2026 CRO.

Next step

Contact bioaccess® · First-in-Human CRO · Brazil · CT.gov hub · InCor · Albert Einstein · CRO in Colombia.

Figures cited from the live ClinicalTrials.gov record NCT03927560 and the published bioaccess® Brazil country page, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the hospital and trial that record supports. The overall status on the live file is UNKNOWN. bioaccess® is not listed on the NCT and no bioaccess® page claims this robotic-PCI study.

If you searched Hospital Israelita Albert Einstein clinical trial, Einstein São Paulo robotic PCI, Pedro Lemos robotic PCI Brazil, or “go direct to Einstein,” you followed a hospital that is the sponsor of a public device-procedure record. Hospital Israelita Albert Einstein in São Paulo is a real tertiary site. It is not the CRO for your investigational device.

bioaccess®’s position is simple and it is not adversarial: Einstein is the site (and, on this NCT, the academic sponsor). The First-in-Human CRO still owns ANVISA / CEP when the investigation is yours, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus Colombia if that is the better file. A hospital-sponsored robotic-PCI protocol does not make Einstein the vendor for a U.S. startup’s next implant.

This page does not clone clinical trials in Brazil. That page stays the country system. This page answers the hospital-named query.

What NCT03927560 actually says (live 23 August 2026)

NCT03927560 — brief title: Robotic-Assisted Percutaneous Coronary Intervention. Official title: a safety and effectiveness study applied to the Brazilian public health system. Organization study ID: Robotic First. Lead sponsor: Hospital Israelita Albert Einstein (class OTHER). Status: UNKNOWN. Estimated start 10 June 2019; estimated completion 10 March 2020; estimated enrollment 83; interventional, single-group, no masking; intervention: robotic-assisted percutaneous coronary intervention; condition: coronary artery disease. Brief summary: PCI is safe but fully operator-dependent and associated with radiation exposure; this study will evaluate robotic-assisted PCI as an alternative to manual operation. Primary outcomes listed: procedure complications and procedure success.

Key inclusion on the record: age ≥ 18; symptomatic ischemic heart disease and/or objective ischemia; elective (non-urgent) PCI; obstructive target lesion(s) > 50% by visual analysis; interventional plan includes robotic manipulation in at least one treatment as judged by the operator; acceptable surgical-revascularization candidate. Key exclusions include STEMI in the prior 48 hours, LVEF < 30%, and creatinine > 2.0 mg/dL or CrCl < 30 ml/min.

The live record lists no facility rows. The hospital appears as sponsor. Central contact: Pedro Lemos, PhD, phone +55 (11) 2151-4306, email pedro.lemos@einstein.br on the public file. No overall official is listed. We will not invent a cath-lab address the NCT omitted, and we will not upgrade UNKNOWN to completed or recruiting.

Read the record as it is: an Einstein-sponsored robotic-PCI safety and effectiveness study aimed at the Brazilian public health system, with 2019–2020 estimated dates and an unknown current status. It is not a first-in-human of a new coronary implant, and it is not a bioaccess® case study.

A hospital sponsor is still not your CRO

Academic hospitals sponsor their own procedure-innovation protocols. That is normal. It does not transfer ANVISA, import, or 812.28 ownership to a U.S. company that later emails the same contact because Google surfaced “Einstein robotic PCI.”

What Einstein can typically do when a sponsor “goes direct”:

• Discuss whether a service line — here, a public contact associated with robotic PCI — has interest and capacity for your protocol, which is not automatic.
• Share institutional CEP calendars and hospital research rules.
• Quote procedure, bed, and local staffing costs for cases they will physically run.

What the hospital is not built to own for your investigational device:

• ANVISA under RDC 837/2023 when your device — not their robotic-PCI technique protocol — is the investigational article.
• CEP packet writing, deficiency cycles, and the Law 14874 clock as a managed workstream.
• Investigational import and accountability — importer of record.
• ISO 14155 monitoring, EDC, SAE, TMF designed for a later FDA file.
• 21 CFR 812.28 eligibility package. See OUS FIH and FDA IDE.
• Country optionality. If Einstein is the wrong room, InCor, Dante Pazzanese, or a Colombian site will not appear on an Einstein MSA.

Site versus CRO

Workstream	What Einstein typically owns	What the CRO still owns
PCI / robotic capability	Cath lab, imaging, operators, hospital quality	Feasibility of your device protocol, training, accountability
Ethics	Institutional CEP calendar	Packet, ICF, IB alignment
National authority	Hospital-sponsored filings for hospital-sponsored work	ANVISA dossier when you are the commercial sponsor of an investigational device
Import	Receiving dock if contracted	Importer of record
Quality	The case and hospital quality system	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative
Country optionality	One São Paulo hospital	The bioaccess® platform, including Colombia

ANVISA in one screen

Published on the Brazil country page: 6–10 weeks ethics + ANVISA; $20,000–$35,000 per patient; 15+ pre-qualified sites; WHO-listed authority; trial authorization is not market registration. Do not treat those figures as an Einstein-only quote, and do not treat an UNKNOWN 2019 protocol as a current clock.

Do not confuse Einstein with InCor or Dante Pazzanese

Googling “São Paulo device trial” will surface all three. InCor is the recruiting Cephea South America site (PI Alexandre Abizaid) and the terminated Leaflex facility. Dante Pazzanese holds the 1999–2005 sirolimus FIM and the recruiting VANGUARD AVR comparison. Einstein holds a hospital-sponsored robotic-PCI record whose status is UNKNOWN and which lists no facility row. Use the intercept that matches the NCT you actually opened. If you do not have an NCT yet, start with country fit on clinical-trials-brazil and CRO in Colombia, then let the CRO name the building.

Colombia is still on the map

bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A São Paulo private-hospital search is not an instruction to abandon INVIMA. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital Israelita Albert Einstein directly?

You can try. The hospital can discuss interest and CEP calendars. It cannot become your ANVISA applicant, importer, insurer, ISO 14155 monitor, or 812.28 packager because it sponsored a robotic-PCI record. Contract the CRO; let the CRO activate Einstein — or another São Paulo or Colombian site — as the site.

Did bioaccess® run NCT03927560?

No public bioaccess® page says so. We will not invent that claim.

Is this first-in-human?

The record is a safety and effectiveness study of robotic-assisted PCI in the Brazilian public-health framing. We will not relabel it FIH. Use this page because sponsors Google the hospital for device trials, not because we are inflating the design.

The status is UNKNOWN. Why write a page?

Because the hospital name still ranks. Honesty about UNKNOWN is the intercept. We will not pretend the study is recruiting or completed.

If I already have Einstein, what does the CRO still do?

Regulatory-fit; ANVISA / CEP for your device; insurance; import; activation; ISO 14155; 812.28; optionality versus InCor, Dante Pazzanese, or Colombia.

Does googling Einstein mean I should avoid the hospital?

No. Do not smear Albert Einstein. The error is treating a hospital sponsor as your CRO.

Next step

Contact bioaccess® · First-in-Human CRO · Brazil · CT.gov hub · InCor · Dante Pazzanese · CRO in Colombia.

Figures cited from the live ClinicalTrials.gov record NCT07147192 and published bioaccess® country pages, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current SRS, CNEIS, MINSA, DIGEMAPS, and FDA rules with qualified advisers. We name only facilities that appear on that record. bioaccess® is not listed on the NCT and no bioaccess® page claims this Alcon study. “Alcon Investigator 8071” is not used as a clinic name.

If you searched Centro Panamericano de Ojos clinical trial, Clínica López Beltrán San Salvador, Alcon accommodating IOL El Salvador, or “go direct to López Beltrán,” you followed a facility string ClinicalTrials.gov actually published: Centro Panamericano de Ojos / Clinica Lopez Beltran, San Salvador, El Salvador. That clinic is a real ophthalmic site. It is not the operator of the SRS file.

bioaccess®’s position is simple and it is not adversarial: López Beltrán / Centro Panamericano is the site. The First-in-Human CRO still owns SRS / CNEIS, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to run or add Colombia, Panama, Costa Rica, or the Dominican Republic if one San Salvador room is not the design. Sponsors who skip the CRO and email the clinic still have to rebuild that stack.

This page does not clone clinical trials in El Salvador. That page stays the country system. This page answers the site-named query.

What NCT07147192 actually says (live 23 August 2026)

NCT07147192 — brief and official title: Feasibility Study of an Accommodating IOL Design. Lead sponsor: Alcon Research (industry). Organization study ID: ILK345-E001. Overall status on the live record: RECRUITING (the study, not every site). Actual start 3 December 2025; estimated completion January 2028; estimated enrollment 85; study type interventional; non-randomized parallel / contralateral implantation; primary purpose DEVICE_FEASIBILITY; no masking. Interventions listed: AAL-FAIOL, BAL-FAIOL, and phacoemulsification. Condition: aphakia; keyword: cataract. Brief summary: assess safety and explore usability and effectiveness of the test product AAL-FAIOL; “This study will be conducted in Central America.”

Design on the record: adult subjects who require cataract surgery in both eyes; one eye receives AAL-FAIOL and the other BAL-FAIOL, surgeries 14–35 days apart; follow-up about one year; the AAL lens may be laser-adjusted after surgery if needed. Primary outcome: cumulative ocular adverse events, including secondary surgical interventions. Ages 22 years and older; not healthy volunteers. Central contact is Alcon Call Center, not a San Salvador investigator name. Study director: Clinical Trial Lead, Surgical, Alcon Research, LLC.

Location rows, copied as listed:

• Clinica 20/20 — San José, Costa Rica — RECRUITING
• Instituto Espaillat Cabral — Santo Domingo, Dominican Republic — NOT_YET_RECRUITING
• Centro Panamericano de Ojos / Clinica Lopez Beltran — San Salvador, El Salvador — NOT_YET_RECRUITING
• Panama Eye Center — Panama City, Panama — RECRUITING

The user-facing memory of this study as “not yet recruiting” is true for the San Salvador row. The overall NCT is recruiting because Costa Rica and Panama already are. We will not flatten that distinction, and we will not invent a local PI the record does not name.

The clinic is a site. The CRO is the operator.

A San Salvador eye clinic can provide phacoemulsification rooms and surgeons who can, when activated, implant an investigational accommodating IOL. That is necessary. It is not sufficient for a device-feasibility file a U.S. board expects to survive FDA review — especially a four-country Central American design.

What the site typically owns: investigator interest, local visit costs, coordination with national ethics once someone files. What the CRO still owns:

• SRS authorization in El Salvador (DNM’s successor since August 2024) and the parallel CNEIS ethics packet.
• For sister rows on the same NCT: MINSA / CNBI in Panama and DIGEMAPS / CONABIOS in the Dominican Republic. Costa Rica’s national desk is a separate country file; we will not invent a regulator name that is not already on a bioaccess® country page in this intercept.
• Investigational import in each country — importer of record.
• ISO 14155 monitoring, EDC, SAE, TMF across sites that are not even recruiting yet.
• 21 CFR 812.28 narrative so contralateral feasibility data is built for a later FDA conversation. Eligibility, not clearance. See OUS FIH and FDA IDE.

Site versus CRO

Workstream	What López Beltrán / Centro Panamericano owns	What the CRO still owns
Cataract / accommodating IOL capability	OR, biometry, implanting ophthalmologists	Protocol feasibility, training, device accountability for AAL-FAIOL / BAL-FAIOL
Ethics	Local coordination	CNEIS packet; sister-country ethics where the other NCT rows sit
National authority	Not a hallway conversation	SRS in El Salvador; MINSA / DIGEMAPS on the other rows
Import	Receiving dock if contracted	Importer of record in each country
Quality	Clinic quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 package
Country optionality	One San Salvador row, currently not yet recruiting	Activation of Panama, Costa Rica, DR, or a Colombia alternative

Sister sites on the same NCT — not this clinic

Do not merge López Beltrán with Clínica Quesada. Quesada is the Zeiss facility (NCT05201027, NCT06192901). Do not merge it with Instituto Espaillat Cabral in Santo Domingo — same Alcon protocol, different country and a different building, distinct from any Laser Center / Batlle GORE listing.

Optional public rows we are not giving their own slugs today: Clinica 20/20 in San José (recruiting on the record) and Panama Eye Center in Panama City (recruiting). Panama Eye Center is the institution later MINIject papers identify as formerly Clínica de Ojos Orillac-Calvo; NCT03193736 (STAR-I MINIject, COMPLETED) lists that Panama City name. Those are public-record facts, not bioaccess® case studies.

SRS / CNEIS in one screen

Published on the El Salvador country page and not re-averaged here: 30–60 day parallel startup; dollarized economy; ~60% cost versus a U.S. program; 98.5% GCP on the published network figure; 21 CFR 812.28 eligibility with ISO 14155, SRS, and CNEIS. Country-level FIH names on that page (Avantec, Ocumedex, Watershed, Horizon) stay country-level. This page will not move them onto López Beltrán.

Colombia is still on the map

bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. An Alcon Central America NCT is not an instruction to abandon INVIMA. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Frequently asked questions

Can I contract Centro Panamericano / López Beltrán directly?

You can try. A clinic can discuss interest and local cataract costs. It cannot become your SRS applicant, multi-country importer, ISO 14155 monitor, or 812.28 packager because Alcon listed it. The San Salvador row is still not yet recruiting. Contract the CRO; let the CRO activate the site — or a sister country that is already recruiting if that is the honest design.

Did bioaccess® run ILK345-E001?

No public bioaccess® page says so, and the NCT does not name a CRO. We will not invent that claim.

Is this first-in-human?

The record’s primary purpose field is DEVICE_FEASIBILITY. That is the honest label. It is an accommodating-IOL feasibility design in Central America, not a press-release we will inflate.

If I already have the clinic name, what does the CRO still do?

Regulatory-fit across the four NCT countries plus Colombia if needed; SRS / CNEIS and the other national packets; insurance; import; activation; ISO 14155 and the 812.28 narrative.

Does googling López Beltrán mean I should avoid the clinic?

No. Do not smear the site. The error is treating the site as the CRO.

Next step

Contact bioaccess® · First-in-Human CRO · El Salvador · CT.gov hub · Quesada · Espaillat Cabral · CRO in Colombia.

Figures cited from live ClinicalTrials.gov records NCT07244939 and NCT05052684 and the published bioaccess® Brazil country page, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the institute and trials those records support. bioaccess® is not listed on either NCT and no bioaccess® page claims Cephea or Leaflex at InCor.

If you searched InCor Cephea, Instituto do Coração HCFMUSP clinical trial, InCor first-in-human mitral, or “go direct to InCor,” you followed a facility name ClinicalTrials.gov published. Instituto do Coração (InCor) — Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — is a real cardiovascular site. It is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: InCor is the site. The First-in-Human CRO still owns ANVISA / CEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if São Paulo is not the only fit. Sponsors who skip the CRO and email the institute still have to rebuild that stack. The hospital does not become a CRO because Abbott or Pi-cardia listed it.

This page does not clone clinical trials in Brazil. That page stays the country system — including the published note that São Paulo’s Hospital das Clínicas is one of the largest medical complexes in Latin America. This page answers the InCor-named query.

What the public NCT file actually says

NCT07244939 — Cephea South America Feasibility Study. Lead sponsor: Abbott Medical Devices. Organization study ID: ABT-CIP-10554. Status: RECRUITING. Actual start 17 June 2025; estimated completion September 2028; estimated enrollment 20; interventional, single-group, no masking; intervention: Cephea Mitral Valve System; conditions: mitral regurgitation and mitral stenosis. Objective on the brief summary: preliminary safety and effectiveness of the Cephea Mitral Valve System for symptomatic mitral valve disease (regurgitation, stenosis, or mixed) when the site heart team judges transcatheter therapy more appropriate than open surgery. Primary outcomes listed: freedom from all-cause mortality; reduction of MR to ≤ Grade I. Key inclusion: MR ≥ Grade III and/or severe mitral stenosis (area ≤ 1.5 cm²), LVEF ≥ 30%. The São Paulo row is Instituto do Coracao (InCor) – HCFMUSP, status RECRUITING, principal investigator Alexandre Abizaid, contact João Mourão. Sister South America rows on the same record: Instituto Nacional del Torax and Hospital Clinico San Borja Arriarán, both Santiago, Chile, both recruiting. Study director: Barathi Sethuraman, Abbott Structural Heart.

NCT05052684 — The Leaflex™ Brazilian Standalone Study. Lead sponsor: Pi-cardia. Status: TERMINATED. Why stopped: “Reprioritization of attention and resources by Sponsor.” Actual start 3 October 2022; actual completion 14 November 2024; actual enrollment 1; intervention: Leaflex™ Performer; condition: aortic valve stenosis; single-group safety and performance design. Facility listed: Instituto do Coração FMUSP Centro de Pesquisa, São Paulo, Brazil. Study director: Hadas Givon, Pi-cardia. No site PI is named on the live location row.

Neither record names a CRO. That is how a sponsor finds InCor without finding the operator. We will not claim bioaccess® ran either study.

InCor is a site. The CRO is the operator.

InCor can provide structural-heart rooms, imaging, and an investigator of Abizaid’s public stature. That is necessary. It is not sufficient for a first-in-human or early-feasibility device study a U.S. board expects to survive FDA review.

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation with a São Paulo operator is not that dossier.
• CEP. Institutional ethics under Law 14874; published country-page cap of 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have InCor” still leaves the packet to write.
• Investigational import into Brazil is a separate permit from the trial authorization and from later ANVISA market registration (RDC 751/2022 / BRH). See importer of record.
• ISO 14155 monitoring, EDC, SAE, TMF — including if you later add the Chilean rows on the Cephea record or a Colombian alternative.
• 21 CFR 812.28 — eligibility of foreign data for FDA submission and review, not clearance. See OUS FIH and FDA IDE.

Site versus CRO

Workstream	What InCor / HCFMUSP typically owns	What the CRO still owns
Structural-heart capability	OR / hybrid room, imaging, implanting physicians, ICU	Protocol feasibility, training, device accountability
Ethics	Institutional CEP calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not a hallway conversation	ANVISA clinical-investigation dossier (RDC 837/2023)
Import	Receiving dock, storage if contracted	Importer of record, permits
Quality	Hospital quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they ran	21 CFR 812.28 narrative
Country optionality	One São Paulo complex (plus Chile on Cephea)	Colombia and the rest of the bioaccess® platform

ANVISA in one screen (from the country page, not a new median)

Published on clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837; per-patient $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority; trial authorization and market registration are separate workstreams. Those figures are country-page figures. They are not InCor-only quotes.

Chile on the same Cephea record is not InCor

NCT07244939 is a South America feasibility, not a São Paulo-only story. Instituto Nacional del Torax (PI Jorge Sandoval) and Hospital Clinico San Borja Arriarán (PI Gabriel Maluenda) are recruiting in Santiago. That is another reason “email InCor” is not a study. A multi-country structural-heart file still needs one operator for import, monitoring, and the English dataset — whether the next case is in São Paulo or Santiago. We are not publishing Chilean intercepts in this wave; we are refusing to pretend those rows do not exist.

Colombia is still on the map

bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A Cephea São Paulo search is not an instruction to abandon INVIMA. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Frequently asked questions

Can I contract InCor directly?

You can try. The institute can discuss investigator interest, local procedure costs, and CEP calendars. It cannot become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Abbott listed Alexandre Abizaid. Contract the CRO; let the CRO activate InCor as the site.

Did bioaccess® run Cephea or Leaflex at InCor?

No public bioaccess® page says so. We will not invent that claim. PercAssist São Paulo remains an unsourced hospital-level name on our press hub and is not assigned to InCor here.

Leaflex enrolled one patient and stopped. Does that smear InCor?

No. The live record says the sponsor reprioritized. That is a sponsor decision, not a reason to attack the institute. Do not smear the site.

If I already have InCor, what does the CRO still do?

Regulatory-fit (Brazil vs Colombia vs a Chile-plus-Brazil design); the ANVISA / CEP packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one São Paulo room is not enough.

Is Colombia still an option?

Yes. Brazil’s published per-patient band is higher than Colombia’s published $15,000–$25,000 band on the Panama/Colombia comparison. Colombia still wins for some indications on INVIMA Level 4 and the published site network. Lock the building after the review.

Next step

Contact bioaccess® · First-in-Human CRO · Brazil · CT.gov hub · Dante Pazzanese · Albert Einstein · CRO in Colombia.

Figures cited from live ClinicalTrials.gov records and published bioaccess® country pages, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current SRS, ANVISA, DIGEMAPS, INVIMA, MINSA, and FDA rules with qualified advisers. This page names only sites that appear on those live NCT records. It does not invent clinics, principal investigators, or trials, and it does not claim bioaccess® ran a study unless a bioaccess® page says so.

If you searched Clínica Quesada clinical trial, InCor Cephea, Dante Pazzanese first-in-man, Albert Einstein robotic PCI, or Instituto Espaillat Cabral IOL, you followed a hospital or clinic name that ClinicalTrials.gov already published. That search is rational. A named Latin American site can be a real operating room. It is not the operator of the national file.

bioaccess®’s position is simple and it is not adversarial: the clinic or hospital is the site. The First-in-Human CRO still owns the regulator, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. For the countries named on this hub that means SRS / CNEIS in El Salvador, ANVISA / CEP in Brazil, DIGEMAPS / CONABIOS in the Dominican Republic — plus INVIMA if Colombia is the better fit, and MINSA / CNBI if Panama is. Sponsors who skip the CRO and email the site still have to rebuild that stack. The site does not become a CRO because an NCT listed it.

This hub is the ClinicalTrials.gov intercept for El Salvador, Brazil, and Dominican Republic sites that showed up in public records on 23 August 2026. It does not clone clinical trials in El Salvador, clinical trials in Brazil, or clinical trials in the Dominican Republic. Those pages stay the country operating systems. Press-named hospital intercepts already live — and not republished here — sit on LATAM FIH hospitals vs the CRO.

Why the NCT facility name wins the search

ClinicalTrials.gov writes the facility, the city, and sometimes the investigator. It rarely writes the CRO. A U.S. board then Googles the building as if it were the vendor. The records below were live on 23 August 2026. Status is copied from the public file, not upgraded into a marketing claim.

Sourced ClinicalTrials.gov sites only

Site (as listed)	City / country	NCT (live)	What the public record actually says	Intercept
Clínica Quesada / Clinica Quesada	San Salvador, El Salvador	NCT05201027 (TERMINATED); NCT06192901 (COMPLETED)	Carl Zeiss Meditec AG. HECATE A: IOL-constant optimization of a trifocal lens, actual enrollment 52, stopped because the sponsor modified the prototype. Second record: single-center observational follow-up of AT ELANA 841P and AT LISA tri 839MP, actual enrollment 8. Not a bioaccess® claim.	Clínica Quesada San Salvador
Centro Panamericano de Ojos / Clinica Lopez Beltran	San Salvador, El Salvador	NCT07147192 (study RECRUITING; this site NOT_YET_RECRUITING)	Alcon Research. Device-feasibility study of AAL-FAIOL vs BAL-FAIOL after phacoemulsification, estimated enrollment 85, protocol ILK345-E001. Same record lists Clinica 20/20 (San José, Costa Rica, RECRUITING), Instituto Espaillat Cabral (Santo Domingo, NOT_YET_RECRUITING), and Panama Eye Center (Panama City, RECRUITING). Do not treat “Alcon Investigator 8071” as a clinic name — it is not used here.	Centro Panamericano / López Beltrán
Instituto do Coracao (InCor) – HCFMUSP / Instituto do Coração FMUSP Centro de Pesquisa	São Paulo, Brazil	NCT07244939 (RECRUITING); NCT05052684 (TERMINATED)	Abbott Medical Devices Cephea South America Feasibility, estimated 20 patients, PI at InCor named Alexandre Abizaid. Pi-cardia Leaflex™ Brazilian Standalone, actual enrollment 1, terminated for sponsor reprioritization. Not a bioaccess® claim.	InCor HCFMUSP
Instituto Dante Pazzanese de Cardiologia / of Cardiology	São Paulo, Brazil	NCT00233792 (COMPLETED); NCT06688448 (RECRUITING)	Historic first-in-man sirolimus-coated Bx VELOCITY stent, start listed December 1999, completion March 2005, enrollment 30, PI Eduardo J Sousa, sponsor Cordis US Corp. That FIM is more than twenty years old — say so. Current VANGUARD (Dafodil® vs INSPIRIS Resilia®) is a hospital-sponsored randomized AVR comparison, estimated 200, ages 18–65. Not a bioaccess® claim.	Dante Pazzanese São Paulo
Hospital Israelita Albert Einstein (sponsor; no separate facility row)	São Paulo, Brazil	NCT03927560 (UNKNOWN)	Hospital-sponsored robotic-assisted PCI safety and effectiveness study applied to the Brazilian public health system, estimated enrollment 83, estimated 2019–2020 dates, contact Pedro Lemos, PhD. Overall status on the live record is UNKNOWN. Not a bioaccess® claim.	Albert Einstein São Paulo
Instituto Espaillat Cabral	Santo Domingo, Dominican Republic	NCT07147192 (this site NOT_YET_RECRUITING)	Same Alcon accommodating-IOL feasibility as López Beltrán. Distinct from any Laser Center / Batlle GORE listing. Not a bioaccess® claim.	Instituto Espaillat Cabral

Sister facilities on NCT07147192 that do not yet have their own intercept: Clinica 20/20, San José, Costa Rica (RECRUITING on the live record) and Panama Eye Center, Panama City (RECRUITING). Panama Eye Center is the same institution later papers call the successor to Clínica de Ojos Orillac-Calvo, which NCT03193736 (STAR-I MINIject, COMPLETED) lists in Panama City. Those are public-record site names, not bioaccess® case studies.

That is the ClinicalTrials.gov list for this hub. If a program is not on it, we do not invent a building. Laser Center, CODET, and a new Ebner slug were searched in CMS before write and were not occupied; Hospital Italiano Asunción is already live and is not republished.

What we will not invent

• We will not claim bioaccess® ran Zeiss HECATE A, the AT ELANA / AT LISA follow-up, Alcon ILK345-E001, Cephea, Leaflex, the 1999–2005 Cordis FIM, VANGUARD, or Einstein robotic PCI.
• Country-page El Salvador programs (Avantec Vascular, Ocumedex, Watershed Therapeutics, Horizon Surgical Systems) stay country-level on clinical-trials-el-salvador. They are not assigned to Clínica Quesada or López Beltrán.
• PAVmed, ReGelTec, Mitralign, and PercAssist São Paulo remain unsourced at hospital level, as on the press hub.
• “Alcon Investigator 8071” is not a clinic.

Site versus CRO — the table that should sit on every NCT-facility search

Workstream	What the clinic / hospital (site) typically owns	What the CRO still owns
Procedure capability	OR, imaging, implanting physicians, local staff	Feasibility against the protocol, training, device accountability
Ethics	Institutional committee calendar, or the national ethics clock the country uses	Packet, ICF, IB alignment, deficiency cycle
National authority	Not a hallway conversation with a surgeon	SRS / CNEIS (El Salvador), ANVISA / CEP (Brazil), DIGEMAPS / CONABIOS (Dominican Republic), INVIMA (Colombia), MINSA / CNBI (Panama)
Investigational import	Receiving dock, storage if contracted	Importer of record, permits, accountability — see importer of record
Quality system	Hospital quality and the case itself	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from the cases they ran	21 CFR 812.28 eligibility package — not a promise of clearance. See OUS FIH and FDA IDE
Country optionality	One building on one NCT row	Colombia, Panama, El Salvador, Brazil, the Dominican Republic, and the rest of the bioaccess® platform if the indication needs it

Going direct to the NCT facility is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation that a U.S. board expects to survive FDA review.

Four authorities, same operator layer

El Salvador (SRS / CNEIS). Published on the El Salvador country page: Superintendencia de Regulación Sanitaria replaced DNM in August 2024; parallel SRS + CNEIS review on one digital platform; 30–60 day startup; dollarized economy; ~60% cost vs a U.S. program; 98.5% GCP on the published bioaccess® network figure. A San Salvador eye clinic can run phacoemulsification. It does not become SRS.

Brazil (ANVISA / CEP). Published on the Brazil country page: RDC 837/2023 dossier; Law 14874 ethics cap of 30 business days; combined ethics + ANVISA 6–10 weeks; per-patient $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority. InCor, Dante Pazzanese, and Einstein can run the case. They do not become the Portuguese ANVISA file, the importer, or the 812.28 packager.

Dominican Republic (DIGEMAPS / CONABIOS). Published on the DR country page: Ministry of Public Health through DIGEMAPS; CONABIOS-overseen RECs (~30 days institutional, ~45 days CONABIOS, up to 120 depending on complexity). Espaillat Cabral is a site on an Alcon record. DIGEMAPS is still the national desk.

Colombia is still on the map (INVIMA). bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A Brazil or El Salvador NCT search is not an instruction to abandon Bogotá. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Why “email the PI” still leaves the FDA file empty

1. A regulatory-fit decision — El Salvador for speed and a dollarized eye-care corridor; Brazil for ANVISA weight, volume, and diversity; Dominican Republic as a nearshore Caribbean option; Colombia when INVIMA Level 4 and the published site network are the better file. Country choice is a review, not an NCT clipping.
2. The national application plus insurance.
3. Importer-of-record and device accountability.
4. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE.
5. A written protocol-to-LPLV operating model — not a hospital “we can start next month” hallway number.

bioaccess® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates first-in-human device studies as a multi-country platform with a U.S. sponsor desk. Project managers and monitors are ACRP-certified. That is the operator layer around a named NCT site.

Frequently asked questions

Can I contract the ClinicalTrials.gov facility directly?

You can try. A clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being listed on an NCT, become your SRS, ANVISA, DIGEMAPS, or INVIMA applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. If the goal is a first-in-human or early-feasibility device study — not a courtesy tour — contract the CRO, then let the CRO contract and activate the site.

Which of these studies did bioaccess® run?

None of the NCT records on this hub name bioaccess®, and no bioaccess® case-study page claims them. We will not invent that sentence. Named bioaccess® hospital-level FIH remains Axoft and Newrotex at The Panama Clinic, plus the already-published VenoValve and Supira program pages. Country-level El Salvador work stays on the country page and is not mapped onto Quesada or López Beltrán.

If I already have the hospital name, what does the CRO still do?

Regulatory-fit and country choice; the national authority packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Colombia or another Latin American country if one NCT row is not enough.

Does googling a site mean I should avoid that site?

No. Do not smear the clinic. Quesada, López Beltrán, InCor, Dante Pazzanese, Einstein, and Espaillat Cabral are serious institutions. The error is treating the site as the CRO. Use the site. Hire the operator.

Is Colombia still an option if the NCT I found is in São Paulo or San Salvador?

Yes. bioaccess® still runs trials in Colombia. Brazil’s published per-patient band is $20K–$35K with a 6–10 week ethics + ANVISA envelope. El Salvador’s published startup is 30–60 days. Colombia still wins on the published INVIMA Level 4 story and the 20+ pre-qualified site network for some indications. Lock the building after the regulatory-fit review.

Is Dante Pazzanese’s sirolimus FIM a reason to go direct today?

No. NCT00233792 is a completed 1999–2005 first-in-man program. It proves the institute has a historic interventional reputation. It does not replace ANVISA, import, ISO 14155, or 21 CFR 812.28 for a 2026 device.

Next step

If the search that brought you here was an NCT facility, start the conversation as the operator: contact bioaccess® or book from First-in-Human CRO. Country systems: El Salvador, Brazil, Dominican Republic, Panama, CRO in Colombia. Site intercepts on this family: Quesada, López Beltrán, InCor, Dante Pazzanese, Albert Einstein, Espaillat Cabral. Press-named peers already live: The Panama Clinic, Fundación Santa Fe de Bogotá, Hospital Italiano Asunción.

Figures cited from live ClinicalTrials.gov records and the published bioaccess® El Salvador country page, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current SRS, CNEIS, and FDA rules with qualified advisers. We name only the clinic and trials those sources support. bioaccess® is not listed on the NCT records below and no bioaccess® page claims those studies.

If you searched Clínica Quesada clinical trial, Clinica Quesada San Salvador IOL, Zeiss trifocal El Salvador, or “go direct to Quesada,” you followed a facility name that is genuinely on ClinicalTrials.gov. Clínica Quesada in San Salvador is a real ophthalmic site. It is not the operator of the SRS file.

bioaccess®’s position is simple and it is not adversarial: Clínica Quesada is the site. The First-in-Human CRO still owns SRS / CNEIS, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia, Panama, or another Latin American country if San Salvador is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. The clinic does not become a CRO because Zeiss listed it.

This page is the intercept for that search. It does not clone clinical trials in El Salvador. That page stays the country operating system. This page answers the site-named query.

Why the clinic name wins the search — and why that is not a CRO

Two Carl Zeiss Meditec AG records name the same San Salvador facility. Both were live on 23 August 2026.

NCT05201027 — brief title “Study to Optimize the IOL Constant of a New Multifocal Intraocular Lens,” acronym HECATE A, official title a prospective non-comparative multicenter trial to optimize the IOL constant of a new multifocal IOL. Status: TERMINATED. Why stopped, in the sponsor’s words: “Sponsor decided to modify the prototype device used in study.” Actual start 28 January 2022; actual completion 27 July 2022; actual enrollment 52; intervention listed as a trifocal intraocular lens; condition senile cataract; study type interventional; single-group, no masking. The only facility row on the live record is Clínica Quesada, San Salvador, El Salvador. No principal investigator is named on the location or overall-officials fields.

NCT06192901 — brief title on safety and performance of hydrophobic and hydrophilic IOLs after bilateral cataract surgery. Status: COMPLETED. Actual start 18 September 2023; actual completion 22 September 2023; actual enrollment 8; study type observational; prospective cohort. The detailed description on the record calls it a retro-prospective, comparative, non-interventional, non-randomized, single center study with one follow-up visit more than 12 months after bilateral cataract surgery using AT ELANA 841P in one eye and AT LISA tri 839MP in the other. The only facility row is Clinica Quesada, San Salvador, El Salvador. Primary outcomes listed: monocular corrected distance visual acuity and slit-lamp examination. Organization study ID: AT ELANA 841P-BER-401-23.

Read those records as they are. HECATE A was an IOL-constant optimization that the sponsor terminated after changing the prototype. The 2023 record is a small, completed, single-center follow-up of two already-implanted Zeiss trifocal models — not a new first-in-human implant series. Neither record names a CRO. That is how a sponsor finds Quesada without finding the operator.

Quesada is a site. The CRO is the operator.

A San Salvador cataract clinic can provide phacoemulsification rooms, biometry, and surgeons who have already handled Zeiss trifocal work. That is necessary. It is not sufficient for a first-in-human or early-feasibility device study a U.S. board expects to survive FDA review.

What a site can typically do when a sponsor “goes direct”:

• Discuss investigator interest and surgical feasibility for an ophthalmic protocol — when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics calendars and local research rules.
• Quote procedure, visit, and local staffing costs for the cases they will physically run.

What the site is not built to own for an investigational device:

• SRS. El Salvador’s national regulatory authority since August 2024 is the Superintendencia de Regulación Sanitaria, which replaced the Dirección Nacional de Medicamentos (DNM). A clinic letter is not an SRS authorization.
• CNEIS. The Comité Nacional de Ética de la Investigación en Salud is the centralized ethics body on the published country page. Parallel SRS + CNEIS filing is CRO work, not a PI email.
• Investigational import and device accountability — see importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a Quesada-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If San Salvador is the wrong room — or if the indication later needs Bogotá or Panama City — a single-clinic MSA will not stretch.

Going direct to Clínica Quesada is how you confirm a room and a surgeon. It is not how you open an investigational file.

Site versus CRO

Workstream	What Clínica Quesada (site) typically owns	What the CRO still owns
Cataract / IOL capability	OR, biometry, implanting ophthalmologists, local staff	Protocol feasibility, training, IOL accountability
Ethics	Local coordination with the national ethics clock	CNEIS packet, ICF, IB alignment
National authority	Not a hallway conversation	SRS clinical-investigation authorization
Import	Receiving dock if contracted	Importer of record, permits
Quality	Clinic quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they ran	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One San Salvador building	Colombia, Panama, Brazil, Dominican Republic if the device needs them

How SRS / CNEIS actually works (the short version this clinic search needs)

Use clinical-trials-el-salvador for the operating line. Facts a sponsor searching this clinic needs on one screen, published there and not re-averaged here:

• SRS established August 2024 as National Regulatory Authority, replacing DNM; digital “one-stop shop” for roughly 550 procedure types; open to pre-submission meetings.
• Parallel SRS + CNEIS submission on a unified digital platform; published startup 30–60 days.
• Dollarized economy; published ~60% cost versus a comparable U.S. program; 98.5% GCP on the published bioaccess® El Salvador network figure.
• Under 21 CFR 812.28, foreign data from El Salvador is eligible for FDA submission and review when the study is run under ISO 14155 with proper SRS authorization and CNEIS approval — eligibility, not a guarantee of clearance.

Country-page FIH examples (Avantec Vascular Sangria®, Ocumedex Vizio™, Watershed Therapeutics WT-03, Horizon Surgical Systems Polaris) are country-level. This page will not move them onto Clínica Quesada. Hospital El Salvador is named on that country page as infrastructure; it is a different building.

Colombia is still on the map

A San Salvador clinic search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. We pick the country the device needs. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Frequently asked questions

Can I contract Clínica Quesada directly?

You can try. The clinic can discuss investigator interest, local cataract costs, and ethics calendars. It cannot become your SRS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because two Zeiss NCT rows named it. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the Zeiss studies at Quesada?

No public bioaccess® page says so, and the NCT records do not name a CRO. We will not invent that claim. For a new ophthalmic device study in San Salvador, hire the CRO that still runs El Salvador files.

Are these first-in-human studies?

Be precise. HECATE A optimized the constant of a new multifocal / trifocal IOL and was terminated when the sponsor modified the prototype. NCT06192901 is a completed eight-patient observational follow-up of AT ELANA 841P and AT LISA tri 839MP already in the bag. Treat Quesada as a named ophthalmic site, not as proof that every future IOL there is FIH.

If I already have the clinic name, what does the CRO still do?

Regulatory-fit (El Salvador vs Colombia vs Panama vs a multi-country design); the SRS / CNEIS packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring and the TMF; the English 812.28 narrative.

Does googling Quesada mean I should avoid the clinic?

No. Do not smear the site. Clínica Quesada is a serious San Salvador eye clinic with two public Zeiss records. The error is treating the site as the CRO.

What about the other San Salvador eye clinic on ClinicalTrials.gov?

Centro Panamericano de Ojos / Clínica López Beltrán is a different facility on NCT07147192 (Alcon accommodating IOL). See that intercept. Do not merge the two clinics, and do not use “Alcon Investigator 8071” as a name for either.

Next step

Start as the operator: contact bioaccess® or First-in-Human CRO. Country system: clinical trials in El Salvador. Same-family hub: ClinicalTrials.gov FIH sites vs the CRO. Sister sites: López Beltrán, Espaillat Cabral. Colombia remains open: CRO in Colombia.

Study facts below are taken only from the live Cardiac Interventions Today item dated 21 August 2026. Principal-investigator hospital titles are labeled as public affiliation, not as a confirmed AVANXA site. General information, not legal or regulatory advice. Confirm current ANVISA, INVIMA, and FDA rules with qualified advisers. PercAssist is not described as a bioaccess® client.

On 21 August 2026, Cardiac Interventions Today reported that the AVANXA feasibility study of the PercAssist extravascular ventricular assist device (eVAD) had enrolled its first patient in São Paulo, Brazil. The indication in that item is extravascular biventricular mechanical circulatory support (MCS) for cardiogenic shock. Enrollment continues in São Paulo under Alexandre Abizaid, MD; Carlos Campos, MD; and Roger Renault Godinho, MD. The company says a United States investigational device exemption (IDE) study is planned after the feasibility study.

Read that as a U.S. board member, not as a trade-press reader. You get a city, three named interventional cardiologists, a first-patient vignette, and a line that the next chapter is a U.S. IDE. You do not get a hospital. You do not get a CRO. That is the pattern: site-direct press that is not even site-direct — city plus KOL, then FDA language, with the operator layer left off the page.

This is not a knock on PercAssist, Inc., and it is not a knock on the investigators. First-in-human MCS in cardiogenic shock is serious medicine. Dr. Campos’s comments in that CIT item — STEMI, SCAI stage D cardiogenic shock, implant in minutes, hemodynamic improvement, vasopressors down — are the clinical sentence a board wants. The operating problem is what the same item omits. A sponsor who copies the playbook — Brazil, a KOL, first patient, then an IDE — still has to own ANVISA, investigational import, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Naming São Paulo does not do that work.

bioaccess® is the First-in-Human CRO that owns that stack in Latin America. This page intercepts the query the press just created. It does not claim PercAssist hired bioaccess®. It does not invent a hospital the press did not name.

What the 21 August 2026 press actually named

Verified live on the CIT page, and only those facts, for the study itself:

• Study: AVANXA feasibility study of the PercAssist eVAD (extravascular ventricular assist device).
• Geography: São Paulo, Brazil. First patient enrolled. Continuing to enroll in São Paulo.
• Indication: extravascular biventricular MCS for cardiogenic shock.
• Named physicians: Alexandre Abizaid, MD; Carlos Campos, MD; Roger Renault Godinho, MD.
• First-patient comments (Dr. Campos): implanted in minutes after STEMI with SCAI stage D CS; hemodynamic performance improved; blood pressures normalized; vasopressors diminished. The same comments add that the technology as described does not require vascular access, anticoagulants, or contrast, with further São Paulo enrollment expected in SCAI C and D.
• U.S. path: a United States IDE study planned after the feasibility study, advised the company.
• Hospital named: none. CRO named: none.

Device press is written for the implant, the city, and the operator of the catheter — not the operator of the file. An IDE sentence then makes the omission look smaller than it is. Feasibility data meant to support an IDE still has to be collected under a quality system a reviewer can read. City-plus-KOL copy does not produce that system.

Public affiliation is not a confirmed AVANXA site

Because the press named no hospital, this page will not invent one. Public affiliation is allowed. A confirmed AVANXA site is not.

Alexandre Abizaid is publicly Diretor Técnico of invasive cardiology at Instituto do Coração (InCor), and he trained at Instituto Dante Pazzanese de Cardiologia (InCor mentors page). Abizaid, Campos, and Godinho also appear together on an InCor / Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) case report (doi 10.36660/abc.202250236i). That is affiliation context. It is not proof AVANXA ran at InCor, Dante Pazzanese, or any other named São Paulo institution. Until PercAssist or a primary study record names the hospital, the honest public file is: São Paulo, three physicians, no site.

A sponsor who Googles Abizaid, InCor, or Dante Pazzanese after CIT has found a public CV, not a vendor. Emailing a KOL tests investigator interest. It does not make you the ANVISA applicant, importer of record, ISO 14155 monitor, or author of a 21 CFR 812.28 narrative.

The pattern: city + KOL, no CRO, then a U.S. IDE

On the hospital intercepts already live, the press at least named a building — The Panama Clinic, Fundación Santa Fe de Bogotá, Hospital Italiano in Asunción. AVANXA is a cleaner version of the same error: the building is missing too. The sequence a U.S. CEO still hears is: Brazil has volume; find the KOL; announce first patient from the city; tell the board an IDE is next.

The first half can be true in a week. The IDE half is a regulatory product. If the file was not built for FDA review — protocol, consent, accountability, monitoring, SAE, TMF — the IDE sentence is a hope. The sourced list on LATAM first-in-human hospitals vs the CRO already refuses to invent a site for country-only programs, including PercAssist São Paulo. This column keeps that promise.

What the press named vs what a CRO still does

Workstream	What the 21 August 2026 press named	What a First-in-Human CRO still does
Geography	São Paulo, Brazil	Country-fit: Brazil vs Colombia vs Panama vs Paraguay for this device and this FDA path — not a city because a wire used it
Investigators	Abizaid, Campos, Godinho	Protocol feasibility, contracts, training, delegation. A public CV is not a site initiation visit
Hospital / site	Not named	Identify, qualify, and activate the actual institution if and when the sponsor names one. Do not invent InCor or Dante Pazzanese from affiliation pages
Indication / device	PercAssist eVAD; extravascular biventricular MCS for cardiogenic shock	Protocol, IB, IFU, and risk file ANVISA and a later FDA reviewer can read
First-patient story	Dr. Campos: STEMI, SCAI D, minutes, hemodynamics, vasopressors down	Source documents, device accountability, logs, AE/SAE, monitoring — the case as a regulated record
National authority	Not discussed	ANVISA investigational path; ethics alignment; deficiency cycle. A KOL quote is not the application
Investigational import	Not discussed	Importer of record, permits, customs, accountability — Importer of record for clinical trial devices in Latin America
Quality system	Not discussed	ISO 14155 monitoring, EDC, SAE, TMF. The press can say “feasibility.” The file has to prove it
U.S. sequel	IDE planned after feasibility	FDA 21 CFR 812.28 packaging of OUS data — eligibility for review, not a promise of IDE approval. Can OUS first-in-human data support an FDA IDE submission?
CRO	Not named	The operator. bioaccess® owns that stack for first-in-human device work in Latin America. This article does not claim PercAssist is a client

If you read AVANXA as a template, the right-hand column is the statement of work. The left-hand column is what the wire will rank for. Winning the query means answering the wire without treating it as a complete operating system.

Brazil is a country file. São Paulo is not a CRO.

ANVISA does not grant an investigational device study because three physicians practice in São Paulo. Ethics do not become optional because the first case went well. Import of an investigational MCS system is not a courier label.

When a sponsor retains bioaccess®, the firm owns that country file: ANVISA, import, ISO 14155, monitoring, and the 21 CFR 812.28 package. The physicians still do the case. The hospital, once named and contracted, still owns the room, the ICU, and institutional ethics. Those are different contracts.

Country choice is not automatic. Brazil can be the right first geography for a given MCS program. It can also be the wrong first geography if clocks, import, or the later FDA story point to Colombia, Panama, or Paraguay. That review is CRO work. It is not a CIT dateline.

Colombia stays on the map

A Brazil first-patient story can arrive with a stale rumor that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, 23 August 2026). Always bioaccess® — Miami headquarters, Colombian legal entity and office, INVIMA clocks managed in-country. We pick the country the device needs. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Colombia stays on CRO in Colombia and Fundación Santa Fe de Bogotá FIH. Panama and Paraguay stay on The Panama Clinic and Hospital Italiano Asunción. Those pages name hospitals the primary sources named. This page does not.

Frequently asked questions

Did the 21 August 2026 CIT coverage name a hospital or a CRO?

No. It names São Paulo, AVANXA, the PercAssist eVAD, the cardiogenic-shock MCS indication, three physicians, Dr. Campos’s first-patient comments, and a planned U.S. IDE after feasibility. No hospital. No CRO. This article will not fill those blanks.

Is InCor or Dante Pazzanese the AVANXA site?

Not on the public file used here. Abizaid’s InCor title and Dante Pazzanese training are public affiliation. The joint InCor/HCFMUSP case report is affiliation context. Neither is PercAssist confirmation that AVANXA enrolled there. Do not contract a building you inferred from a CV.

Is PercAssist a bioaccess® client?

This page does not say that. bioaccess® is the First-in-Human CRO explaining the operator layer the press left out.

If the press already has first-patient quotes, what is left for a CRO?

ANVISA and ethics; investigational import and device accountability; contracts, training, and activation of the actual site once named; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset; and 21 CFR 812.28 packaging if a U.S. IDE is truly the sequel. Dr. Campos can describe a case. The CRO has to make the case survive a monitor and a reviewer.

Should a sponsor avoid Brazil, or these investigators?

No. Do not smear PercAssist or the PIs. São Paulo interventional cardiology is not the problem. The error is treating a city-plus-KOL wire as a complete first-in-human operating system.

Can bioaccess® still run the study in Colombia instead — or as well?

Yes, when the device and the FDA path say so. bioaccess® still runs trials in Colombia. Brazil, Colombia, Panama, and Paraguay are country options on one platform, not a loyalty test to last week’s dateline.

Next step

If the search that brought you here was PercAssist, AVANXA, São Paulo MCS, or “Brazil first-in-human without a CRO,” start as the operator: contact bioaccess® or book from First-in-Human CRO. Keep the hospital-vs-CRO rule on LATAM FIH hospitals vs the CRO and Colombia on CRO in Colombia. The CIT item remains the source for the study facts. The CRO remains the source for the file.

Figures cited from published bioaccess® pages and named Hancock Jaffe / enVVeno and MassDevice coverage, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current INVIMA and FDA rules with qualified advisers. We name only the hospital, PI, and trial those sources support.

If you searched Fundación Santa Fe de Bogotá clinical trial, FSFB first-in-human, VenoValve Bogotá, or “go direct to Santa Fe,” you are following a hospital name that is genuinely in the public file. Fundación Santa Fe de Bogotá is a real first-in-human site in Colombia. It is not the operator of the INVIMA file.

bioaccess®’s position is simple and it is not adversarial: FSFB is the site. The First-in-Human CRO still owns INVIMA, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Panama or another Latin American country if Bogotá is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. The hospital does not become a CRO because a 2018 press release named it.

This page is the intercept for that search. It does not clone CRO in Colombia or the results essay enVVeno VenoValve first-in-human trial, Colombia. Those pages stay the country system and the program narrative. This page answers the site-named query.

Why the hospital name wins the search — and why that is not a CRO

Device press writes the implant, the city, the hospital, and the committee. It rarely writes the CRO. The VenoValve first-in-human is the clean public example for Bogotá.

On 9 August 2018, Hancock Jaffe Laboratories (now enVVeno Medical) announced Medical Research Committee approval at Fundación Santa Fe de Bogotá (FSFB) for first-in-human testing of the VenoValve® bioprosthetic venous valve, after prior FSFB Ethics Committee approval. The same release is explicit about the next national step: the company would gather information to apply to INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), “the Colombian equivalent of the U.S. Food and Drug Administration,” because INVIMA approval is required to import investigational medical devices and conduct human clinical trials in Colombia. Live source: enVVeno / Hancock Jaffe, 9 August 2018. MassDevice reported the same FSFB committee sequence the same week.

That sentence is the whole intercept. The hospital committee can say yes. The national import and trial permit is still INVIMA. A site MSA does not replace it.

Later public follow-up names the investigator. Venous News coverage of two-year data at SVS VAM 2021 identifies Jorge Ulloa (Fundación Santa Fe–Universidad de los Andes, Bogotá) as PI. The live bioaccess® results page states the same PI, an 11-patient FIH at FSFB, and 3-year AVF 2023 outcomes: 63% reflux, 64% rVCSS, 83% VAS, zero relapses and zero venous-ulcer recurrences. Ethics on that page: 18 days in Colombia versus an estimated six months in the EU. SAVVE, the U.S. pivotal, is described as commencing October 2021.

The 2018 sponsor releases do not name a CRO. That is how a sponsor finds FSFB without finding the operator. bioaccess®’s VenoValve results page lists FSFB in its Colombia site-selection set, plus INVIMA submissions and full clinical operations. We will not invent a sentence the 2018 copy does not contain. For a new device FIH at this hospital, hire the CRO that still runs Colombia files.

FSFB is a site. The CRO is the operator.

A Bogotá university hospital can provide operating rooms, vascular imaging, and an investigator who has already taken a bioprosthetic venous valve through first-in-human follow-up. That is necessary. It is not sufficient for a first-in-human device study a U.S. board expects to survive FDA review.

What a site can typically do when a sponsor “goes direct”:

• Discuss investigator interest and surgical feasibility with a PI such as Dr. Jorge Ulloa’s service — when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics-committee calendars and hospital research rules (the same FSFB Ethics Committee / Medical Research Committee pair Hancock Jaffe cited).
• Quote procedure, bed, and local staffing costs for the cases they will physically run.

What the site is not built to own for an investigational device:

• INVIMA. Hancock Jaffe’s own 2018 language already separated FSFB committee approval from the national permit and import. That split has not gone away.
• Investigational import. Ethics letter plus investigator’s brochure plus an importation permit — end-to-end work, not a PI email.
• Clinical trial insurance. Required. Ask for a protocol-specific premium; we will not invent a Santa Fe-only number here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The hospital runs the case. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-site and multi-country optionality. bioaccess® publishes 20+ pre-qualified Colombian sites in Bogotá, Cali, Medellín, and Barranquilla. If FSFB is not the right room — or if the indication later needs Panama — a single-hospital MSA will not stretch.

Going direct to Fundación Santa Fe is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

How INVIMA actually works (the short version a hospital search needs)

Use CRO in Colombia for the operating line. The facts a sponsor searching this hospital needs on one screen:

INVIMA issues the clinical-trial permit for investigations. Ethics review sits with the site’s comité de ética. Those are two clocks. Hancock Jaffe’s 2018 release is a public walkthrough of that split: FSFB ethics, then FSFB medical-research committee, then INVIMA for import and the human trial.

Published bioaccess® facts we will not average into a new median:

• On the VenoValve results page: ethics committee approval in 18 days for that Colombia FIH, versus ~6 months estimated in the EU.
• On clinical-trials-panama’s Colombia comparison: Colombia ethics 4–6 weeks; per-patient $15,000–$25,000 (versus Panama 3–5 weeks and $12,000–$22,000).
• On CRO in Colombia: 30+ historical FIH device studies; 20+ pre-qualified sites; INVIMA as a PAHO/WHO Level 4 authority; Miami HQ; local Colombian entity and office.

Ask for a protocol-specific calendar. Do not treat a hospital hallway estimate as INVIMA clearance. bioaccess® manages the submission and keeps the reviewer relationship in-country; that is CRO work, not site work.

All bioaccess® Colombia protocols are designed under ISO 14155 and informed consent / ethics requirements so the dataset can be discussed with FDA under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval.

What the VenoValve public file actually supports — and what it does not

We will stay inside sourced sentences.

• Device: VenoValve, a porcine / bioprosthetic venous valve intended for surgical implant in the deep venous system for severe chronic venous insufficiency (Hancock Jaffe 2018; bioaccess® results page).
• Site: Fundación Santa Fe de Bogotá, Bogotá, Colombia.
• PI: Dr. Jorge Ulloa (bioaccess® results page; Venous News / SVS VAM 2021 follow-up).
• FIH size on the bioaccess® page: 11 patients.
• 3-year numbers on that page: 63% reflux, 64% rVCSS, 83% VAS; 0% ulcer recurrence; 0% overall relapse as published there.
• U.S. next step on that page: SAVVE pivotal commenced October 2021.
• Not claimed here: that the 2018 release named bioaccess®, or that FSFB is the only Colombian site we use.

What the CRO still does after you have a hospital name

Once FSFB is on the slide, the remaining job is the one sponsors skip when they go site-direct:

1. Regulatory-fit, not tourism. Colombia is still a jurisdiction we execute in. It is not automatically the right country for every indication. Country choice is a review, not a 2018 clipping.
2. Protocol, IB, ICF, insurance, and the INVIMA packet.
3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan — at FSFB if it is the right site, or at another pre-qualified Colombian hospital if it is not.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action. See Can OUS first-in-human data support an FDA IDE submission?.
6. A 12-month protocol-to-LPLV written guarantee on the FIH-12™ model published on our country and comparison pages — not a hospital “we can start next month” hallway number.

Do not smear the hospital — and do not confuse commercial “first in LATAM” with FIH

Fundación Santa Fe de Bogotá is a serious institution. This page is not a critique of FSFB. It is a correction of the vendor model. Use the hospital. Hire the operator.

A different Bogotá brand will also appear in “first in Latin America” results: LaCardio / Fundación Cardioinfantil (Aurora™ EV-ICD, Dr. William Bautista). That is a commercial first implant, not FIH, and not an FSFB claim.

We will not invent FSFB as the site for PAVmed, ReGelTec, Avantec, Watershed, Mitralign, OcuMedex, or PercAssist. See the hub: LATAM FIH hospitals vs the CRO.

Colombia is still on the map

A Santa Fe or Panama Clinic search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. INVIMA clocks are managed in-country through the local entity, not watched from a Miami-only docket. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Site versus CRO

Workstream	FSFB / the site	bioaccess® / the CRO
Procedure	Vascular OR, imaging, local staff, PI service	Protocol fit, training, device accountability
Ethics / research committee	Institutional review (the 2018 FSFB pair)	Packet, ICF, IB, deficiency responses
National authority	Not the permit holder by being named in press	INVIMA clinical-trial permit and correspondence
Import	Receiving and storage if contracted	Importer of record — Hancock Jaffe already said INVIMA is required to import
Quality / FDA	Source documents from the cases	ISO 14155 + 21 CFR 812.28 narrative

Frequently asked questions

Can I contract Fundación Santa Fe de Bogotá directly?

You can try. FSFB can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in Hancock Jaffe’s 2018 releases, become your INVIMA applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO that still runs Colombia first-in-human files, then let the CRO activate FSFB — or another pre-qualified site — as the hospital.

Who was the PI for the VenoValve FIH?

Dr. Jorge Ulloa, as stated on the live bioaccess® results page and in public two-year follow-up coverage. That fact does not make the PI your CRO.

What does the CRO still do if the hospital is already identified?

Regulatory-fit and country choice; the INVIMA and ethics packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Panama or another Colombian site if FSFB is not enough. The hospital still does the surgery.

Is Colombia still recommended for new FIH?

Yes. bioaccess® still runs clinical trials in Colombia. We do not tell sponsors to take new first-in-human work out of the country. INVIMA review can move, stall, or ask again; a local entity treats that as a file problem. Panama remains available when the country page’s speed and bilingual profile fit the device better. See The Panama Clinic intercept if that is the hospital you actually found.

Next step

If the search that brought you here was Santa Fe or VenoValve, start as the operator: contact bioaccess®. Country system: CRO in Colombia. Program source: VenoValve Colombia results. Hub: LATAM FIH hospitals vs the CRO. Other sourced sites: The Panama Clinic, Hospital Italiano Asunción. Case studies: Axoft, Newrotex.

Figures cited from published bioaccess® pages and named Supira Medical / PR Newswire coverage, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current DINAVISA and FDA rules with qualified advisers. We name only the hospital, PI, and trial those sources support.

If you searched Hospital Italiano Asunción clinical trial, Italian Hospital Paraguay first-in-human, Supira pVAD Paraguay, or “go direct to the site in Asunción,” you are following a hospital name that is genuinely in the public file. The Italian Hospital in Asunción is a real first-in-human cardiovascular site. It is not the operator of the DINAVISA file.

bioaccess®’s position is simple and it is not adversarial: Hospital Italiano is the site. The First-in-Human CRO still owns DINAVISA, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia, Panama, or another Latin American country if Paraguay is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. The hospital does not become a CRO because a September 2022 press release named it.

This page is the intercept for that search. It does not clone the program essay Supira Medical first-in-human trial, Paraguay. That page stays the narrative. This page answers the site-named query.

Why the hospital name wins the search — and why that is not a CRO

Device press writes the implant, the city, the hospital, and the surgeons. It rarely writes the CRO. Supira Medical’s pVAD first-in-human is the clean public example for Asunción.

On 16 September 2022, Supira Medical, Inc. — a Shifamed portfolio company — announced it had initiated its first-in-human clinical study, “performed by principal investigator, Adrian Ebner, M.D., Head of the Cardiovascular Department at the Italian Hospital Asuncion Paraguay.” The study is described as prospective, single-arm, single-center, evaluating safety and performance of a low-profile, high-flow percutaneous ventricular assist device to support hemodynamics in patients undergoing high-risk PCI. U.S. advisors named as present for the first cases: Dr. Gagan Singh (UC Davis), Dr. Susheel Kodali (NewYork-Presbyterian / Columbia), and Dr. Azeem Latib (Montefiore). CEO comment in that release: Dr. Nitin Salunke. Live sources: Supira Medical, 16 September 2022 and the matching PR Newswire wire.

That release names the hospital and the PI. It does not name a CRO. That is how a sponsor finds Hospital Italiano Asunción without finding the operator. The live bioaccess® program page places the same FIH at the Italian Hospital in Asunción in September 2022 with the same PI, then reports the broader South American experience as 70+ patients treated with zero bleeding or access-site complications, FDA Breakthrough Device Designation, a U.S. Early Feasibility Study initiated November 2024, and FDA approval of the SUPPORT II pivotal in April 2026 — all as published on that page.

This article will not invent a sentence the 2022 sponsor copy does not contain. It will say what is true now: if you are googling this hospital for a new first-in-human device study, the CRO you want is the one that already publishes Paraguay cardiovascular FIH operations and still runs the rest of the Latin American platform.

Hospital Italiano is a site. The CRO is the operator.

An Asunción cardiovascular department can provide the cath lab, imaging, and an investigator who has already taken a next-generation pVAD through first cases with visiting U.S. advisors in the room. That is necessary. It is not sufficient for a first-in-human device study a U.S. board expects to survive FDA review.

What a site can typically do when a sponsor “goes direct”:

• Discuss investigator interest and procedural feasibility with a service such as Dr. Adrian Ebner’s — when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote procedure, bed, and local staffing costs for the cases they will physically run.

What the site is not built to own for an investigational device:

• DINAVISA. Paraguay’s national sanitary authority (Dirección Nacional de Vigilancia Sanitaria) is the file a sponsor actually needs for an investigational device. A hallway conversation with a surgeon is not that file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email.
• Clinical trial insurance. Required. Ask for a protocol-specific premium; we will not invent an Asunción-only number here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The hospital runs the case. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. Eligibility is not clearance. Supira’s later U.S. EFS and SUPPORT II path, as published on the bioaccess® page, is exactly why the early Latin American dataset has to be built as a file, not as a souvenir implant.
• Multi-country optionality. If Paraguay enrollment or the indication later needs Colombia or Panama, a single-hospital MSA will not stretch.

Going direct to Hospital Italiano is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

How DINAVISA sits next to the hospital (the short version)

Use the program page for the Supira narrative. The facts a sponsor searching this hospital needs on one screen:

Paraguay was selected, on the bioaccess® page, for regulatory speed versus a U.S. IDE-first path, plus investigator expertise at the Italian Hospital. That is a country-and-site rationale. It is not a claim that the hospital issues the national permit.

DINAVISA is the national sanitary authority. Ethics sits with the institutional committee. Import sits on a permit. Monitoring sits on ISO 14155. Those layers are why a CRO exists after you already know Dr. Ebner’s name.

We will not invent a median DINAVISA day-count. The clocks we will repeat are already published elsewhere on bioaccessla.com and are country-specific, not Asunción-specific: Panama ethics 3–5 weeks and 6–8 weeks to first patient with bioaccess® coordination on clinical-trials-panama; Colombia ethics 4–6 weeks and per-patient $15,000–$25,000 on that same comparison; VenoValve’s 18-day ethics figure lives on the Colombia results page, not here. Ask for a Paraguay protocol-specific calendar.

All bioaccess® Latin American device protocols are designed under ISO 14155 so the dataset can be discussed with FDA under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval.

What the Supira public file actually supports — and what it does not

• Device: next-generation low-profile, high-flow pVAD for hemodynamic support during high-risk PCI (sponsor release; bioaccess® page).
• Site: Italian Hospital / Hospital Italiano, Asunción, Paraguay.
• PI: Dr. Adrian Ebner, Head of the Cardiovascular Department (sponsor release).
• Start: first-in-human initiated September 2022 (16 September 2022 announcement).
• Design on the sponsor release: prospective, single-arm, single-center.
• Broader South America numbers on the bioaccess® page: 70+ patients; zero bleeding or access-site complications as published there; FDA Breakthrough Device Designation; U.S. EFS November 2024; SUPPORT II pivotal FDA-approved April 2026.
• Not claimed here: that the 2022 Supira release named bioaccess®; that Hospital Italiano is the only cardiovascular site in Paraguay; that 70+ is an Asunción-only census (the bioaccess® page says South America); that PAVmed, ReGelTec, Avantec, Watershed, Mitralign, OcuMedex, or PercAssist were done in this hospital.

What the CRO still does after you have a hospital name

1. Regulatory-fit, not tourism. Paraguay has a public cardiovascular FIH precedent at this hospital. It is not automatically the right country for every indication. bioaccess® still runs trials in Colombia and Panama; country choice is a review, not a 2022 clipping.
2. Protocol, IB, ICF, insurance, and the DINAVISA packet.
3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action. See Can OUS first-in-human data support an FDA IDE submission?.
6. A 12-month protocol-to-LPLV written guarantee on the FIH-12™ model published on our country and comparison pages — not a hospital hallway number.

bioaccess® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates first-in-human device studies as a multi-country platform with a U.S. sponsor desk. Project managers and monitors are ACRP-certified. That is the operator layer around a named Asunción site.

Do not smear the hospital

Hospital Italiano Asunción and Dr. Ebner’s cardiovascular service are serious clinical resources. This page is not a critique of the site. Visiting U.S. advisors in the 2022 release are a signal of procedural seriousness, not a substitute for a CRO quality system. Use the hospital. Hire the operator.

We will not add an Asunción address to programs that only name a country. See the hub: LATAM FIH hospitals vs the CRO. If the hospital you actually typed was The Panama Clinic or Fundación Santa Fe de Bogotá, use those intercepts instead of stretching this one.

Colombia is still on the map

A Paraguay or Panama hospital search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Site versus CRO

Workstream	Hospital Italiano / the site	bioaccess® / the CRO
Procedure	Cath lab, imaging, CV department, PI	Protocol fit, training, device accountability
Ethics	Institutional committee calendar	Packet, ICF, IB, deficiency responses
National authority	Not the permit holder by being named in press	DINAVISA
Import	Receiving and storage if contracted	Importer of record
Quality / FDA	Source documents from the cases	ISO 14155 + 21 CFR 812.28 narrative
Next country	One building in Asunción	Colombia (INVIMA) and Panama (MINSA/CNBI) still on the platform

Frequently asked questions

Can I contract Hospital Italiano Asunción directly?

You can try. The hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in Supira’s 16 September 2022 release, become your DINAVISA applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the Italian Hospital as the site.

Who was the PI for the Supira pVAD FIH?

Dr. Adrian Ebner, Head of the Cardiovascular Department at the Italian Hospital Asunción, as stated by Supira Medical on 16 September 2022. That fact does not make the PI your CRO.

What does the CRO still do if the hospital is already identified?

Regulatory-fit and country choice; the DINAVISA and ethics packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Colombia or Panama if Asunción is not enough. The hospital still does the procedure.

Is this the same as a commercial “first in LATAM” implant?

No. Supira’s 2022 Asunción cases are a first-in-human investigational program. A commercial first implant — for example LaCardio’s Aurora™ EV-ICD story in Bogotá — is launch activity, not this pathway. Do not mix the two when you brief a board.

Next step

If the search that brought you here was Hospital Italiano or Supira Paraguay, start as the operator: contact bioaccess®. Program source: Supira Paraguay. Hub: LATAM FIH hospitals vs the CRO. Other sourced sites: The Panama Clinic, Fundación Santa Fe de Bogotá. Country systems: clinical trials in Panama, CRO in Colombia. Case studies: Axoft, Newrotex.