Rewritten 27 September 2026. Site facts come only from live ClinicalTrials.gov records checked that day. Regulator, cost, and timeline lines are copied from the published bioaccess® post El Salvador first-in-human cost and timeline vs the United States. Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice.
Sponsors planning a first-in-human (FIH) or early-feasibility device study in El Salvador usually start by asking which sites have done this kind of work before. The public answer is on ClinicalTrials.gov. This page compares the El Salvador facilities that appear there with device work, using registry counts and statuses only. It does not rank sites on reputation, and it does not repeat claims the registry does not support.
How to read the counts
- ALL n — ClinicalTrials.gov records that list the facility (all spellings) as an El Salvador location.
- DEVICE n — those records that include an intervention of type DEVICE.
- Status — copied from the record’s overall status field (for example RECRUITING, ACTIVE_NOT_RECRUITING, COMPLETED).
The four sites at a glance
| Site (as listed) | ALL n / DEVICE n | Most relevant record | Status | Named on the record | Intercept |
|---|---|---|---|---|---|
| Clínica Quesada / Clinica Quesada SA de CV, San Salvador | 3 / 2 | NCT06990074 — Horizon Surgical Systems, Polaris early feasibility, robot-assisted cataract surgery, estimated 30 | RECRUITING | Site contact Gabriel Quesada (CONTACT) | Clínica Quesada |
| Centro Panamericano de Ojos / Clinica Lopez Beltran, San Salvador | 2 / 1 | NCT07147192 — Alcon Research, accommodating intraocular lens device feasibility, estimated 85, four sites (Costa Rica, the Dominican Republic, El Salvador, Panama) | ACTIVE_NOT_RECRUITING | No local investigator named | López Beltrán |
| Centro de Diabetes Ocular El Dios de Israel, S.A (city field “Colonia Escalón”) | 1 / 1 | NCT06591117 — Ocumedex, Vizio Aqueous Microshunt for refractory glaucoma, estimated 50 | RECRUITING | Site contact Joaquin Flores, Doctor (CONTACT) | El Dios de Israel |
| Hospital Nacional Zacamil / Hospital Zacamil, San Salvador | 2 / 1 | NCT07508592 — Seger Surgical Solutions, SEGER-FIH device feasibility in laparoscopic gastrointestinal surgery, 10 enrolled (actual) | COMPLETED | Principal investigator Francisco José Alabi Montoya, MD | Zacamil |
Why these four
We started from every El Salvador location on ClinicalTrials.gov and kept named facilities with a device record that is active or recently completed. Generic location strings such as “Ministerio de Salud” are not named facilities, so they are not ranked here. Hospital Nacional El Salvador has one device record (NCT07406919), listed as NOT_YET_RECRUITING with an estimated start (February 2026) that has passed, so it is not ranked either. The first three sites are eye clinics with current ophthalmic device records. For the fourth place we compared Hospital Nacional Zacamil with Basic Health International, San Salvador:
- Zacamil: one completed device-feasibility record whose brief summary calls it a first-in-human study, with actual enrollment (10), actual dates, and a named site principal investigator.
- Basic Health International: one recruiting device record (a thermal ablation treatment study with an estimated 5,000 participants) and one observational screening record whose estimated completion date has passed.
For a page about FIH and early-feasibility sites, Zacamil is the better-supported choice: its record is labeled first-in-human and feasibility, and its results fields are actual rather than estimated. Basic Health International is covered below and on its own page.
Site by site
1. Clínica Quesada (San Salvador)
Three records list this clinic. NCT06990074 (Horizon Surgical Systems Inc.) is an early-feasibility, single-arm study of the Polaris System for robot-assisted cataract surgery: RECRUITING, actual start 23 September 2025, estimated enrollment 30, estimated primary completion August 2026 and study completion October 2026. Clinica Quesada SA de CV is the only listed site, and the site contact is Gabriel Quesada. The estimated primary completion date has passed and the record was last updated 5 January 2026. The other two records are Carl Zeiss Meditec AG studies: NCT05201027 (HECATE A, trifocal intraocular lens constant optimization, TERMINATED 2022, 52 enrolled) and NCT06192901 (observational follow-up, COMPLETED 2023, 8 enrolled). More: Clínica Quesada San Salvador.
2. Centro Panamericano de Ojos / Clínica López Beltrán (San Salvador)
NCT07147192 (Alcon Research, “Feasibility Study of an Accommodating IOL Design”) is ACTIVE_NOT_RECRUITING, with actual start 3 December 2025, estimated enrollment 85, and estimated completion October 2026. It lists four sites: Costa Rica, the Dominican Republic, El Salvador, and Panama. The record names no local investigator. The same clinic, listed as Centro Panamericano de Ojos, also appears on NCT02486237, an observational diabetes-complications cohort sponsored by Clínica Los Yoses (COMPLETED 2016, 225 enrolled). More: Centro Panamericano de Ojos / López Beltrán.
3. Centro de Diabetes Ocular El Dios de Israel
NCT06591117 (Ocumedex, “The Vizio Clinical Study”) tests the Vizio Aqueous Microshunt in refractory glaucoma: RECRUITING, actual start 21 March 2026, estimated enrollment 50, estimated primary completion January 2028 and study completion March 2029. It is the only location, the site contact is listed as Joaquin Flores, Doctor, and no principal investigator is named. More: Centro de Diabetes Ocular El Dios de Israel.
4. Hospital Nacional Zacamil (San Salvador)
NCT07508592 (Seger Surgical Solutions, acronym SEGER-FIH) evaluated the SEGER device in elective laparoscopic gastrointestinal surgery: COMPLETED, actual start 17 February 2026, actual completion 5 June 2026, actual enrollment 10, primary purpose DEVICE_FEASIBILITY. Overall officials: Francisco José Alabi Montoya, MD (Hospital Nacional Zacamil), principal investigator; Barry Salky, MD (Icahn School of Medicine at Mount Sinai), study director. The hospital’s other record, NCT00625599, is a completed observational study of fractures in older adults that started in 2008. More: Zacamil National Hospital.
Other El Salvador facilities you may see named
Basic Health International (San Salvador) — ALL 2 / DEVICE 1
NCT07461818 (POC, sponsor Basic Health International, Inc.) is a RECRUITING cervical pre-cancer treatment study of the IRIS™ Thermal Ablation Device, actual start 1 January 2026, estimated enrollment 5,000; overall principal investigators Karla Alfaro, MD and Rachel Masch, MD. NCT07232355 (PROGRESS, sponsor Atila Biosystems Inc.) is an observational screening study listed as RECRUITING, but its estimated completion (June 2026) has passed. More: Basic Health International San Salvador and Karla Alfaro, MD.
Hospital de Diagnóstico (San Salvador) — ALL 2 / DEVICE 0
The registry lists two related spellings on two oncology drug trials, both Phase 3 and both COMPLETED: NCT01966471 (Hoffmann-La Roche, adjuvant HER2-positive breast cancer, actual start 31 January 2014; site listed as “Hospital Diagnostico Escalón”) and NCT02594371 (Athenex, oral paclitaxel versus intravenous paclitaxel in metastatic breast cancer, actual start 2 December 2015; site listed as “Hospital Diagnotico Clinica Oncologica & Cancer Research”). The registry shows no device records and no ophthalmology records for this hospital.
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.
What a site does and does not own
A named site provides rooms, investigators, and patients for the cases it runs. It does not own the SRS authorization, the CNEIS packet, investigational import, clinical trial insurance, ISO 14155 monitoring, or the 21 CFR 812.28 package. Those sit with the sponsor and its contract research organization (CRO). Each intercept page linked above sets out that split for its site.
Frequently asked questions
Which El Salvador sites have first-in-human device experience on the registry?
On 27 September 2026, the only El Salvador record in this comparison whose summary calls it first-in-human is NCT07508592 at Hospital Nacional Zacamil (COMPLETED, 10 enrolled). Clínica Quesada has a recruiting early-feasibility record (NCT06990074), and López Beltrán is a site on an Alcon device-feasibility record (NCT07147192).
How long does study startup take in El Salvador?
The live El Salvador hub publishes a 30–60 day study-startup band via parallel SRS and CNEIS review on one digital platform. Confirm a study-specific calendar.
Who regulates clinical investigations in El Salvador?
The Superintendencia de Regulación Sanitaria (SRS), which replaced the former Dirección Nacional de Medicamentos (DNM) in August 2024. Ethics stays centralized at CNEIS.
Did bioaccess® run the studies listed here?
None of these records names bioaccess®, and no bioaccess® page claims them.
Related reading
- Clinical trials in El Salvador
- El Salvador first-in-human cost and timeline vs the United States
- ClinicalTrials.gov FIH sites in LATAM vs the CRO
- El Salvador CNEIS/SRS trial vs registro
Planning an El Salvador device study? Contact bioaccess®.