Facts cited from the live ClinicalTrials.gov record NCT06591117, checked 27 September 2026, and the published bioaccess® post El Salvador first-in-human cost and timeline. General information, not legal or regulatory advice. Confirm current El Salvador and U.S. regulatory and ethics rules with qualified advisers. We name only the facility and the site contact the record lists. bioaccess® is not listed on this record and no bioaccess® page claims this study.
If you searched Centro de Diabetes Ocular El Dios de Israel, Ocumedex Vizio El Salvador, Vizio microshunt clinical trial, or “go direct to El Dios de Israel,” you followed a facility string ClinicalTrials.gov actually published: Centro de Diabetes Ocular El Dios de Israel, S.A, El Salvador. It is a real ophthalmic site on a recruiting device study. It is not a first-in-human (FIH) contract research organization (CRO), and it is not the operator of the national file.
bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The CRO still owns the Superintendencia de Regulación Sanitaria (SRS) and Comité Nacional de Ética de la Investigación en Salud (CNEIS) filings, investigational import, insurance, ISO 14155 monitoring, and the 21 CFR 812.28 package.
What NCT06591117 says (checked 27 September 2026)
NCT06591117 — brief title “The Vizio Clinical Study.” Lead sponsor: Ocumedex. Status: RECRUITING. Actual start 21 March 2026; estimated enrollment 50; estimated primary completion January 2028; estimated study completion March 2029. First posted 19 September 2024; last update posted 10 July 2026.
- Intervention: Vizio Aqueous Microshunt (type DEVICE).
- Condition: refractory glaucoma. Brief summary: evaluate the safety and efficacy of the Vizio Aqueous Microshunt for the treatment of refractory glaucoma.
- Primary outcomes listed: efficiency of intraocular pressure (IOP) reduction measured by applanation tonometry, and safety through adverse event reporting.
- Design fields: interventional; primary purpose TREATMENT; phase not applicable; ages 22 to 85.
- Location row, copied as listed: Centro de Diabetes Ocular El Dios de Israel, S.A — city field “Colonia Escalón” — El Salvador — site status RECRUITING. It is the only location on the record.
- Named people: the site contact is listed as “Joaquin Flores, Doctor” with the role CONTACT. The record lists two sponsor central contacts and no overall official (no principal investigator is named).
Registry count for this facility string on 27 September 2026: ALL 1 / DEVICE 1 (one record, and it has a device intervention). The record does not call the study first-in-human, and neither do we. It does not name a CRO.
Why this page exists
The published El Salvador country page names Ocumedex Vizio™ among its country-level FIH examples. ClinicalTrials.gov now ties that program to one named facility. This page answers the facility-name search and keeps the facts to the registry. The bioaccess® ClinicalTrials.gov hub lists this facility with the same record.
The site is the site. The CRO is the operator.
What El Dios de Israel can typically do when a sponsor “goes direct”:
- Discuss investigator interest and whether a protocol fits an existing service.
- Share local research rules and how the cases would physically run.
- Estimate local visit, staffing, and procedure effort for the cases they will run.
What a site is not built to own for an investigational device:
- SRS authorization and the CNEIS packet, filed in parallel on the national digital platform.
- 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 premium here.
- ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF).
- The 21 CFR 812.28 package. Eligibility is not clearance, and a site agreement does not produce it.
Going direct is how you confirm a room and a person. It is not how you open an investigational file.
Site versus CRO
| Workstream | What the clinic (site) typically owns | What the CRO still owns |
|---|---|---|
| Glaucoma surgery capability | Operating room, surgeons, local staff, source documents | Protocol fit, training, device accountability |
| Ethics | Local coordination | CNEIS packet, informed consent, investigator’s brochure alignment |
| National authority | Not the permit holder by appearing on an NCT row | SRS investigation authorization |
| Import | Receiving and storage 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 — eligibility, not clearance |
Regulator, ethics, timeline, and cost (published figures)
These lines are copied from the published bioaccess® post El Salvador first-in-human cost and timeline vs the United States, not re-averaged here:
- The live El Salvador hub already publishes a 30–60 day study-startup band via parallel review by the Superintendencia de Regulación Sanitaria (SRS) and the Comité Nacional de Ética de la Investigación en Salud (CNEIS) on one digital platform. That band is investigation authorization plus ethics — not commercial registro.
- SRS replaced the former Dirección Nacional de Medicamentos (DNM) in August 2024. Ethics stays centralized at CNEIS.
- The El Salvador hub already publishes roughly 60% cost savings versus equivalent U.S. programs, plus a dollarized (U.S. dollar) economy. That is orientation from the country page, not a formal study for your device.
Ask for a study-specific calendar before you put a single date on a board slide. A site email is not an SRS authorization. Trial authorization and commercial registro are separate files; see CNEIS/SRS trial authorization vs registro.
All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Foreign clinical data can be eligible for U.S. Food and Drug Administration (FDA) submission and review under 21 CFR 812.28. Eligibility is not clearance or approval. See OUS FIH and FDA IDE.
Do not merge the San Salvador eye clinics
Three named El Salvador eye facilities carry active device records on ClinicalTrials.gov. Keep them apart:
- Clínica Quesada — Horizon Surgical Systems’ Polaris early-feasibility study (NCT06990074, RECRUITING) plus two Zeiss intraocular lens records.
- Centro Panamericano de Ojos / Clínica López Beltrán — Alcon accommodating intraocular lens feasibility study (NCT07147192, ACTIVE_NOT_RECRUITING).
- Centro de Diabetes Ocular El Dios de Israel — this page, Ocumedex Vizio (NCT06591117, RECRUITING).
Same country, different buildings, different sponsors. Registry-wide context sits on the ClinicalTrials.gov FIH sites vs the CRO hub.
Colombia note
Colombia remains a strong market-access geography and a historical first-in-human geography for bioaccess®. The public line still stands: INVIMA clinical-trial approval timelines have become unpredictable, so bioaccess® does not currently recommend Colombia for new first-in-human execution. We pick the country the device needs.
Frequently asked questions
Can I contract Centro de Diabetes Ocular El Dios de Israel directly?
You can try. A clinic can discuss interest and local surgical costs. It cannot become your SRS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Ocumedex listed it. Contract the CRO; let the CRO activate the site if it fits your protocol.
Did bioaccess® run the Vizio study?
No public bioaccess® page says so, and the record does not name a CRO. We will not invent that claim.
Who is the investigator?
The record names no principal investigator. It lists “Joaquin Flores, Doctor” as the site contact (role CONTACT). We do not add a title, specialty, email, or phone the record does not show.
Is this a first-in-human study?
The record does not say so. Its primary purpose field is TREATMENT, with estimated enrollment 50. Cite it as a recruiting glaucoma device study at a named El Salvador site.
Next step
Start as the operator: contact bioaccess® or First-in-Human CRO. Country system: clinical trials in El Salvador. Sister sites: Clínica Quesada, López Beltrán.
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