Facts cited from live ClinicalTrials.gov records NCT07461818 and NCT07232355 (checked 27 September 2026), plus collaborator fields on NCT06815939 and NCT05431699, 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. bioaccess® is not listed on these records and no bioaccess® page claims these studies.
If you searched Basic Health International El Salvador, IRIS thermal ablation clinical trial San Salvador, cervical pre-cancer trial El Salvador, or “go direct to Basic Health International,” you followed a facility string ClinicalTrials.gov actually published: Basic Health International, San Salvador, El Salvador. On the registry it is both a study sponsor and a study site. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the national file.
bioaccess®’s position is simple and it is not adversarial: a site is a 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 for a sponsor’s own device.
What the registry says (checked 27 September 2026)
Registry count for the facility string “Basic Health International” in El Salvador: ALL 2 / DEVICE 1. Both records are listed as RECRUITING.
NCT07461818 — POC (device, RECRUITING)
NCT07461818 — acronym POC, brief title “Point of Care – Triage and Treatment for Cervical Pre-cancer.” Lead sponsor: Basic Health International, Inc.; collaborators The Cleveland Clinic, Liger Medical Llc, and Medical College of Wisconsin. Status: RECRUITING. Actual start 1 January 2026; estimated enrollment 5,000; estimated primary completion January 2029; estimated study completion August 2029. First posted 10 March 2026; last update posted 28 August 2026.
- Intervention: IRIS™ Thermal Ablation Device (type DEVICE), used in a modified two-probe thermal ablation protocol.
- Conditions: cervical precancer, cervical intraepithelial neoplasia (CIN), and human papillomavirus (HPV) infection. Eligibility: women aged 30 to 49.
- Primary outcome listed: 1-year cure rate of CIN2+. The summary also describes a retrospective look at an automated visual evaluation (AVE) triage method against histopathology.
- Named people, copied as listed: overall principal investigators Karla Alfaro, MD and Rachel Masch, MD (both affiliated with Basic Health International, Inc.); central contact Karla Alfaro, MD; site contact Leticia Lopez, MD.
- Location row: Basic Health International — San Salvador — El Salvador — RECRUITING. It is the only location on the record.
NCT07232355 — PROGRESS (observational, RECRUITING, record looks stale)
NCT07232355 — acronym PROGRESS, brief title “Prevention of Cervical Cancer Using the Genotyping Screening and Same-day Self-sampling.” Lead sponsor: Atila Biosystems Inc.; collaborator Basic Health International, Inc. Study type observational; estimated enrollment 5,000; actual start 24 August 2023. Status: RECRUITING, but the estimated primary and study completion dates (June 2026) have passed and the last update was posted 19 November 2025, so treat the status as unconfirmed. Locations are listed in El Salvador, Honduras, and the United States. The San Salvador row is Basic Health International, with Karla Alfaro, MD as site contact.
Where Basic Health International appears without a site row
The registry also lists Basic Health International, Inc. as a collaborator on two Ministry of Health studies — NCT06815939 (OPTICS, sponsor DL Analytics, RECRUITING) and NCT05431699 (SCALE, sponsor The Cleveland Clinic, ACTIVE_NOT_RECRUITING) — whose San Salvador location is listed as “Ministerio de Salud,” not Basic Health International. We do not count those as site rows here.
None of these records calls itself first-in-human, and none names a CRO.
The site is the site. The CRO is the operator.
What Basic Health International 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.
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.
Named investigator
The person who appears most often on these records has her own page: Karla Alfaro, MD. That page lists her registry roles exactly as ClinicalTrials.gov shows them.
Do not merge this site with other San Salvador sites
Basic Health International is not Hospital Nacional Zacamil and not the San Salvador eye clinics (Clínica Quesada, López Beltrán, El Dios de Israel). The Ministry of Health locations above are listed as generic strings and are not this facility.
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 Basic Health International directly for a device study?
You can try. A site can discuss interest and local visit costs. It cannot become your SRS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because a registry record listed it. Contract the CRO; let the CRO activate the site if it fits.
Did bioaccess® run POC or PROGRESS?
No public bioaccess® page says so, and the records do not name a CRO. We will not invent that claim.
Is NCT07461818 a first-in-human study?
The record does not say so. It is a recruiting treatment study of a thermal ablation device with an estimated 5,000 participants.
Next step
Start as the operator: contact bioaccess® or First-in-Human CRO. Country system: clinical trials in El Salvador. Registry hub: ClinicalTrials.gov FIH sites vs the CRO.