Figures cited from the live ClinicalTrials.gov record NCT07786025 (first posted 25 August 2026) and the published bioaccess® Dominican Republic country page, verified 25 August 2026. General information, not legal or regulatory advice. Confirm current DIGEMAPS, CONABIOS, and FDA rules with qualified advisers. We name only the clinic and trial those sources support. No principal investigator is named on the NCT location row; we will not invent one. Distal Inc. is not claimed as a bioaccess® client.
If you searched Clínica Canela clinical trial, Clinica Canela La Romana AVF, DisTal arteriovenous fistula, Distal Inc. Dominican Republic, or “go direct to the site in La Romana,” you followed a facility string ClinicalTrials.gov actually published on 25 August 2026. Clínica Canela in La Romana is a real hospital. It is not the operator of the DIGEMAPS file.
bioaccess®’s position is simple and it is not adversarial: Clínica Canela is the site. The First-in-Human CRO still owns DIGEMAPS, CONABIOS-overseen ethics, 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 La Romana is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. A new NCT row does not become a CRO.
This page is the intercept for that search. It does not clone clinical trials in the Dominican Republic. That page stays the country operating system. Sister Santo Domingo intercepts stay on their own buildings: Laser Center and Instituto Espaillat Cabral. This page answers the La Romana query.
Why the hospital name wins the search — and why that is not a CRO
NCT07786025 is a new ClinicalTrials.gov listing. The registry’s own dates, retrieved 25 August 2026: study first submitted 21 August 2026; first posted 25 August 2026. Brief title: DisTal Arterio-Venous Fistula Feasibility. Official title: Feasibility Study to Assess the Safety and Efficacy of the DisTal Arterio-Venous Fistula Procedure. Acronym: DisTal. Lead sponsor: Distal Inc., class INDUSTRY. No collaborator is listed. No CRO is listed.
Status on that snapshot: ACTIVE_NOT_RECRUITING. Actual start 2 December 2024. Estimated primary completion and study completion 1 March 2027. Actual enrollment 100. Study type: interventional; single-group; no masking; primary purpose treatment; phase N/A. Condition: end-stage renal disease requiring hemodialysis. The only location row is Clinica Canela, La Romana, Dominican Republic.
The intervention, in the registry’s words, is a device named DisTal. Radial vein and radial artery are accessed percutaneously. Guidewires are aligned. The device, “featuring a circular blade on a torque shaft,” is advanced over both wires, pulls the vessels together, and cuts a 7–10 mm opening to establish a non-surgical, endovascular arteriovenous fistula. The primary outcome is the proportion of participants whose vein at the DisTal AVF site enlarges versus pre-procedure ultrasound within 100 days.
Read the record as it is. The official title is a feasibility study. The registry does not label it first-in-human. One hundred actual participants is larger than a classic five-to-thirty-patient early feasibility. Start of 2 December 2024 means the cases were already running when the NCT first appeared. That is still a site-direct leak: a sponsor searching the device or the hospital now lands on La Romana with no CRO in the public copy.
The hospital itself is independently real. The public site clinicacanela.com presents Clínica Dr. Canela at Ave. Libertad #44, La Romana, República Dominicana — emergency, inpatient rooms, laboratory, and imaging. That confirms a building. It does not confirm a DIGEMAPS applicant, an importer of record, or an ISO 14155 monitor. We will not add a PI name the NCT did not publish.
Canela is a site. The CRO is the operator.
A La Romana hospital can provide an operating room, imaging, dialysis-access caseload, and a receiving dock. That is necessary. It is not sufficient for an investigational percutaneous AVF study a U.S. board expects to survive FDA review — including a later IDE conversation after OUS feasibility.
What a site can typically do when a sponsor “goes direct”:
- Discuss investigator interest and procedural feasibility for a vascular-access protocol — 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, visit, and local staffing costs for the cases they will physically run.
What the site is not built to own for an investigational device:
- DIGEMAPS. The Ministry of Public Health, through the Directorate General of Medicines, Food and Health Products, is the national authority. A hallway conversation with a surgeon is not that file.
- CONABIOS-overseen ethics. Institutional REC review and CONABIOS-level review are country-system work, already described on the Dominican Republic page.
- 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 La Romana-only premium 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. The NCT’s own oversight flag on 25 August 2026 listed the study as not an FDA-regulated device; that does not make a later U.S. file automatic.
- Multi-country optionality. If La Romana enrollment, imaging, or the indication later needs Santo Domingo, Bogotá, or Panama City, a single-hospital MSA will not stretch.
Going direct to Clínica Canela is how you confirm a room. It is not how you open an investigational file.
Site versus CRO
| Workstream | What Clínica Canela (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | OR, imaging, vascular-access caseload, local staff | Protocol fit, training, DisTal-class device accountability |
| Ethics | Institutional REC calendar | Packet, ICF, IB, CONABIOS coordination |
| National authority | Not the permit holder by being listed on an NCT | DIGEMAPS |
| Import | Receiving and storage if contracted | Importer of record |
| 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 |
| Country optionality | One building in La Romana | Colombia (INVIMA), Panama (MINSA/CNBI), and the rest of the platform |
How DIGEMAPS and CONABIOS sit next to the hospital
Use clinical-trials-dominican-republic for the full pathway. Facts a sponsor searching this hospital needs on one screen, already published there and not re-averaged here:
- The Ministry of Public Health through DIGEMAPS is the national regulatory authority for health products, including medical devices.
- Ethics oversight is coordinated by CONABIOS, which supervises Research Ethics Committees. Institutional REC review averages about 30 days. CONABIOS-level review averages about 45 days (up to 120 depending on complexity).
- Protocols follow the Declaration of Helsinki and CIOMS guidelines.
- Under 21 CFR 812.28, foreign clinical data from the Dominican Republic is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper DIGEMAPS authorization and CONABIOS-overseen ethics approval. Eligibility is not a guarantee of clearance or approval.
- bioaccess®’s published Dominican Republic cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study. Headline ~40% faster / ~30% lower per-patient figures on llms.txt and LATAM FIH benchmarks 2026 are the same class of estimate.
We will not invent a Clínica Canela-only day-count. Ask for a protocol-specific calendar. A hospital email is not a DIGEMAPS approval.
What the Distal public file actually supports — and what it does not
- Device: DisTal percutaneous / endovascular arteriovenous fistula system, as described on NCT07786025.
- Sponsor: Distal Inc. (industry). No collaborator. No CRO named.
- Site: Clinica Canela, La Romana, Dominican Republic — the only location row.
- Design: interventional feasibility; actual n=100; actual start 2 December 2024; active, not recruiting on the 25 August 2026 first-post snapshot.
- PI: not named on the registry location or contacts we retrieved. We will not fill that blank.
- Not claimed here: that the NCT named bioaccess®; that Distal Inc. is a bioaccess® client; that this registry row is labeled first-in-human; that Clínica Canela is the only Dominican device site; that we have Distal outcomes; that a 100-patient feasibility is the same as a five-patient FIH.
Santo Domingo already has sourced intercepts that are different buildings: Laser Center (GORE GDI EFS, NCT05557058) and Instituto Espaillat Cabral (Alcon accommodating IOL row on NCT07147192). Do not merge La Romana into Santo Domingo.
What the CRO still does after you have a hospital name
- Regulatory-fit, not tourism. The Dominican Republic is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
- Protocol, IB, ICF, insurance, and the DIGEMAPS / CONABIOS packet.
- Importer-of-record and device accountability.
- Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative — see Can OUS first-in-human data support an FDA IDE submission?.
bioaccess® was founded in 2010 and coordinates first-in-human and early-feasibility device studies as a multi-country platform with a U.S. sponsor desk. That is the operator layer around a named La Romana site. We will not rewrite NCT07786025 as a bioaccess® study.
Do not smear the hospital
Clínica Canela / Clínica Dr. Canela is a serious La Romana institution. This page is not a critique of the site. A public feasibility listing is a signal that a building was used. It is not a substitute for a CRO quality system. Use the hospital. Hire the operator.
Colombia is still on the map
A Dominican Republic 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, 25 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™.
Frequently asked questions
Can I contract Clínica Canela directly?
You can try. The hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named on NCT07786025, become your DIGEMAPS applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate Clínica Canela as the site if it is the right site for your protocol.
Is this a first-in-human study?
Be precise. The official title is a feasibility study to assess safety and efficacy of the DisTal AVF procedure. The registry does not use the words first-in-human. Actual enrollment is 100, with an actual start in December 2024, and the NCT itself first posted on 25 August 2026. Treat Clínica Canela as a named device-feasibility site, not as proof that every future implant there is FIH.
Who is the principal investigator?
The NCT location row we retrieved on 25 August 2026 does not name one. We will not invent a name. A missing PI field is another reason the public file is not a CRO package.
Did bioaccess® run the Distal study at Canela?
No public bioaccess® page says so, and NCT07786025 does not name a CRO. We will not invent that claim. For a new vascular-access or other device study in the Dominican Republic, hire the First-in-Human CRO that already publishes DIGEMAPS / CONABIOS operations.
What does the CRO still do if the hospital is already identified?
Regulatory-fit and country choice; the DIGEMAPS and CONABIOS 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 La Romana is not enough. The hospital still does the procedure.
Does googling Canela mean I should avoid the hospital?
No. Do not smear the site. Clínica Canela is a real La Romana hospital with a newly posted Distal Inc. feasibility row. The error is treating the site as the CRO.
Next step
If the search that brought you here was Clínica Canela, La Romana, Distal Inc., or DisTal AVF, start as the operator: contact bioaccess® or First-in-Human CRO. Hub: ClinicalTrials.gov FIH sites vs the CRO. Other sourced Dominican sites: Laser Center Santo Domingo, Instituto Espaillat Cabral. Country: Dominican Republic, CRO in Colombia, Panama.
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