Corporativo Hospital Satélite Naucalpan: Named GT Metabolic MAGNET Feasibility Site, Not the COFEPRIS File

Figures cited from the live ClinicalTrials.gov record NCT07085741 (study first posted 25 July 2025; last update posted 11 September 2026) and the published bioaccess® Mexico country page, verified 11 September 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics-committee, and FDA rules with qualified advisers. We name only the facility and the trial those sources support. We do not publish site contact emails or phone numbers here. GT Metabolic Solutions is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

If you searched Corporativo Hospital Satélite clinical trial, Hospital Satelite Naucalpan MAGNET, GT Metabolic Mexico duodeno-ileostomy, MAGNET 2 Study Mexico, or “go direct to the Naucalpan site,” you followed a facility string ClinicalTrials.gov still publishes on NCT07085741. Corporativo Hospital Satelite in Naucalpan, Mexico is a real named facility on that record. It is not the operator of the COFEPRIS file.

bioaccess®’s position is simple and it is not adversarial: Corporativo Hospital Satelite is the site. The First-in-Human CRO still owns COFEPRIS, institutional ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if Naucalpan is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. A completed location row does not become a CRO.

This page is the intercept for the Naucalpan / Hospital Satélite query. It does not clone clinical trials in Mexico. That page stays the country operating system. Sibling Mexican intercepts stay on their own buildings: Especialistas de la Piel y Cirugía Monterrey, New Hope Fertility Centre Mexico City, and Reina Madre Mexico City. Do not merge them into this slug.

Why the hospital name wins the search — and why that is not a CRO

NCT07085741 is an industry device listing. The registry’s own dates, retrieved 11 September 2026: study first submitted 8 April 2025; QC submitted 18 July 2025; first posted 25 July 2025; last update submitted 9 September 2026; last update posted 11 September 2026. Brief title: Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System in Mexico. Official title ends with the sponsor acronym MAGNET 2 Study. Organization study ID: GTM-002. Lead sponsor: GT Metabolic Solutions, Inc., class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed.

Design on the 11 September 2026 snapshot: interventional; intervention model description on the record says an open-label multicenter plan for up to 25 subjects at up to 3 study centers in Mexico; allocation N/A; no masking; primary purpose treatment; phase N/A; actual enrollment 10; status COMPLETED. Actual start 7 May 2025; actual primary completion 19 October 2025; actual completion 21 June 2026. Conditions: obesity; type 2 diabetes. The brief summary’s own words: evaluate the feasibility / performance, safety and initial efficacy of the MAGNET System, DI Biofragmentable for side-to-side duodeno-ileostomy diversion.

Intervention, in the registry’s words: a device — MAGNET System, DI Biofragmentable; anastomoses achieved by magnetic compression. Primary outcomes listed: magnet placement (≥90% alignment during the index procedure); natural magnet passage without surgical re-intervention through 90 days; anastomosis patency confirmed radiologically through 90 days. The registry’s oversight module records no data monitoring committee, and marks the study as not FDA-regulated drug and not FDA-regulated device — a sponsor-entered flag about this listing, not a statement about what a later U.S. filing would require.

Location rows currently published:

• Corporativo Hospital Satelite — the only location on the record — Naucalpan, Mexico. No site contact or overall official is printed on the public row as of the 11 September 2026 snapshot. We will not invent a principal investigator name.

Read the record as it is. A single Mexican facility string, an actual enrollment of 10, feasibility language in the brief summary, an industry sponsor, and no CRO in the public copy. That is the site-direct leak: a sponsor searching MAGNET System Mexico, GT Metabolic Naucalpan, or Hospital Satélite metabolic anastomosis now lands on a named hospital with no operator between them and the file. MAGNET 2 naming and earlier MagDI listings elsewhere on ClinicalTrials.gov mean we will not invent a “world’s first implant” claim for this page; the intercept is the Mexico facility string, not a global first-case press release.

Naucalpan is a site. The CRO is the operator.

A Naucalpan hospital campus can provide operating rooms, metabolic/bariatric procedural capacity, imaging for anastomosis patency, and local research staffing when contracted. That is necessary. It is not sufficient for an investigational-device study a U.S. board expects to survive later scrutiny.

What a site can typically do when a sponsor “goes direct”:

• Discuss investigator interest and procedural feasibility for a magnetic-anastomosis 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:

• COFEPRIS. Clinical investigations sit under the Ley General de Salud and its implementing regulations. The submission is in Spanish: protocol, investigator brochure, informed consent, ethics approval, proof of insurance. A conversation with a Naucalpan hospital is not that dossier.
• Institutional ethics. Ethics-committee review under NOM-012-SSA3-2012 sits in front of the COFEPRIS file, and the committee is tied to the host institution once the site is chosen.
• Investigational import. Bringing an unapproved device into Mexico is a separate workstream from the trial authorization and from a later commercial registro sanitario. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a site-only premium here.
• ISO 14155 monitoring, EDC, adverse-event reporting, and the TMF.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. If one Mexican campus is not enough, a single-hospital MSA will not stretch to Colombia, Panama, Chile, or Brazil.

Going direct to Corporativo Hospital Satelite is how you confirm a room. It is not how you open an investigational file.

Site versus CRO

How COFEPRIS and ethics sit next to the hospital

Use clinical trials in Mexico for the full pathway. Facts a sponsor searching this facility needs on one screen, already published there and not re-averaged here:

• Ethics at 4–6 weeks under NOM-012-SSA3-2012; COFEPRIS review at 4–8 weeks after ethics clearance; 2.8-month median start-up (attributed on that hub to NIH ClinRegs).
• Published per-patient range $18,000–$30,000; 10+ pre-qualified sites across Mexico City, Guadalajara, and Monterrey.
• The ~30-working-day COFEPRIS figure is registro sanitario / vía abreviada — a commercial market-access clock, not this trial clock.
• All COFEPRIS submissions are in Spanish, including protocol, investigator brochure, and informed consent.
• Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not a guarantee of clearance or approval.
• bioaccess®’s published cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study.

We will not invent a facility-only day count. Ask for a protocol-specific calendar. A hospital email is not a COFEPRIS authorization.

What the GT Metabolic public file actually supports — and what it does not

• Device: MAGNET System, DI Biofragmentable (magnetic side-to-side duodeno-ileostomy anastomosis), as described on NCT07085741.
• Sponsor: GT Metabolic Solutions, Inc. (industry). No collaborator. No CRO named.
• Site: Corporativo Hospital Satelite, Naucalpan, Mexico — the only location row on the 11 September 2026 snapshot.
• Design: interventional, phase N/A; actual n=10; COMPLETED; actual start 7 May 2025; actual completion 21 June 2026; brief summary uses feasibility / performance language; official title labels the file MAGNET 2 Study (org ID GTM-002).
• Named investigator (as published): none on the public location or overall-official fields as of this snapshot. We do not invent one.
• Not claimed here: that the NCT named bioaccess®; that GT Metabolic is a bioaccess® client; that we have MAGNET outcomes; that this listing is an FDA IDE; that the hospital holds a COFEPRIS authorization because it is printed on a registry row; that this Mexico row is the world’s first MagDI implant.

What the CRO still does after you have a hospital name

• Regulatory-fit, not tourism. Mexico is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet — in Spanish.
• Importer of record and device accountability for the investigational system.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
• Optionality if one Estado de México campus is not enough.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background on why registry rows keep outranking operators: ClinicalTrials.gov FIH sites vs the CRO.

Frequently asked questions

Can I contract Corporativo Hospital Satelite directly?

You can try. The facility can discuss investigator interest, local procedure costs, and ethics-committee calendars. It cannot become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because GT Metabolic listed Naucalpan. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the MAGNET 2 study?

No public bioaccess® page says so. We will not invent that claim. This page intercepts the search; it does not claim the study.

The registry says this is not an FDA-regulated device study. Does 21 CFR 812.28 still matter?

It matters the moment you want the data to travel. That sponsor-entered flag describes this listing. If a U.S. submission is ever the goal, the GCP, ethics, and documentation conditions in 21 CFR 812.28 are what make foreign data eligible for FDA submission and review — and eligibility is still not clearance.

Is this a first-in-human study?

The brief summary uses feasibility / performance language and the official title calls the file MAGNET 2 Study. Earlier MagDI / MAGNET System listings for GT Metabolic exist on ClinicalTrials.gov outside Mexico. We intercept the Naucalpan facility string; we do not invent a global first-implant headline from this NCT alone.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Naucalpan search is not an instruction to abandon INVIMA. See CRO in Colombia.