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
- 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.
- The national application plus insurance.
- Importer-of-record and device accountability.
- 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.
- 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.