Figures cited from the live ClinicalTrials.gov record NCT07802431 (study first posted 3 September 2026; last update posted 3 September 2026) and the published bioaccess® Mexico country page, verified 3 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, the investigator, and the trial those sources support. We do not publish site contact emails or phone numbers here. Jeisys Medical is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.
If you searched Especialistas de la Piel y Cirugía clinical trial, Jeisys Linear Z Mexico, LinearZ HIFU body contouring study, Hector Leal Leal Monterrey, or “go direct to the Monterrey site,” you followed a facility string ClinicalTrials.gov published for the first time on 3 September 2026. Especialistas de la Piel y Cirugía, S.C. in Monterrey, Nuevo León 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: Especialistas de la Piel y Cirugía 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 Monterrey is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A recruiting location row does not become a CRO.
This page is the intercept for the Monterrey query. It does not clone clinical trials in Mexico. That page stays the country operating system. Sibling Mexican intercepts stay on their own buildings: Centro de Dermatología de Monterrey, CODET Vision Institute Tijuana, and Instituto de Oftalmología Conde de Valenciana. Do not merge them into this slug.
Why the clinic name wins the search — and why that is not a CRO
NCT07802431 is a brand-new industry device listing. The registry’s own dates, retrieved 3 September 2026: study first submitted 27 August 2026; QC submitted 1 September 2026; first posted 3 September 2026; last update posted 3 September 2026. Brief title: Clinical Evaluation of Linear Z for Body Contouring. Official title: Prospective, Single-center, Single-arm Clinical Research Evaluating the Safety and Effectiveness of Linear Z for Non-invasive Body Contouring of the Abdomen and Flanks. Organization study ID: LIN-BD-01-2026. Lead sponsor: Jeisys Medical Inc, class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed.
Design on the 3 September 2026 snapshot: interventional; single-center, single-arm; allocation N/A; no masking; primary purpose treatment; phase N/A; estimated enrollment 30; status RECRUITING. Estimated start 1 September 2026; estimated primary completion 20 December 2026; estimated completion 31 December 2026. Condition: non-invasive body contouring. Registry keywords: body contouring; high-intensity focused ultrasound (HIFU); localized adiposity; fat reduction.
Intervention, in the registry’s words: a device — high intensity focused ultrasound. Participants receive a single treatment with the LinearZ focused ultrasound device to the lower abdomen and bilateral flanks, delivered at specific depths within subcutaneous tissue per the sponsor-approved treatment manual, with roughly 90 days of follow-up. 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:
- Especialistas de la Piel y Cirugía, S.C. — the only location on the record — RECRUITING. The registry prints the geography as city “Nuevo León,” state “Monterrey,” ZIP 64060, Mexico. We report that as published; the two fields appear transposed on the row and we will not silently rewrite a sponsor’s entry.
- Named site contact on that row: Hector Leal Leal, Dr. Central contact on the record: Narendra Kumar, Dr., PhD, Jeisys. We do not reprint their direct contact details here.
Read the record as it is. A single Mexican site, an estimated 30 participants, a 90-day endpoint window, an industry sponsor in Korea, and no CRO in the public copy. That is the site-direct leak: a sponsor searching LinearZ, Jeisys, or Monterrey body contouring now lands on a named clinic with no operator between them and the file.
Monterrey is a site. The CRO is the operator.
A Monterrey dermatology and surgery practice can provide treatment rooms, standardized photography and 3D imaging, subjects with localized abdominal and flank adiposity, and an investigator the registry already named. 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 an energy-device protocol — when that service is available and appropriate for your device, which is not automatic.
- Share institutional ethics-committee calendars and clinic research rules.
- Quote procedure, visit, and local staffing costs for the sessions 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 Monterrey dermatologist 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 room is not enough, a single-clinic MSA will not stretch to Colombia, Panama, or Costa Rica.
Going direct to Especialistas de la Piel y Cirugía is how you confirm a room. It is not how you open an investigational file.
Site versus CRO
| Workstream | What the Monterrey clinic (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | Treatment room, HIFU sessions, photography and 3D imaging, local staff | Protocol fit, training, device accountability |
| Ethics | Institutional committee calendar and local rules | Packet, ICF, IB alignment, deficiency cycle (NOM-012-SSA3-2012) |
| National authority | Not the permit holder by being listed on an NCT | COFEPRIS clinical-investigation file, in Spanish |
| Import | Receiving and storage if contracted | Importer of record for the investigational system |
| Quality | Clinic quality and the treatment session | ISO 14155 monitoring, EDC, AE reporting, TMF |
| FDA conversation | Source documents from sessions they run | 21 CFR 812.28 narrative — eligibility, not clearance |
| Country optionality | One Monterrey practice | Colombia (INVIMA) and the rest of the bioaccess® platform |
How COFEPRIS and ethics sit next to the clinic
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 clinic email is not a COFEPRIS authorization.
What the Jeisys public file actually supports — and what it does not
- Device: LinearZ high-intensity focused ultrasound for non-invasive body contouring of the lower abdomen and flanks, as described on NCT07802431.
- Sponsor: Jeisys Medical Inc (industry). No collaborator. No CRO named.
- Site: Especialistas de la Piel y Cirugía, S.C., Monterrey / Nuevo León, Mexico — the only location row, RECRUITING.
- Design: single-center, single-arm, phase N/A; estimated n=30; estimated start 1 September 2026; ~90-day follow-up.
- Named investigator (as published): Hector Leal Leal, Dr., site contact on the location row.
- Not claimed here: that the NCT named bioaccess®; that Jeisys is a bioaccess® client; that we have LinearZ outcomes; that this listing is an FDA IDE; that the clinic holds a COFEPRIS authorization because it is printed on a registry row.
What the CRO still does after you have a clinic 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 Nuevo León room 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 Especialistas de la Piel y Cirugía directly?
You can try. The facility can discuss investigator interest, local session 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 Jeisys listed Monterrey. Contract the CRO; let the CRO activate the site.
Did bioaccess® run the Linear Z 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.
Why does the record print Nuevo León as the city and Monterrey as the state?
Because that is what the sponsor entered. Monterrey is the city and Nuevo León is the state. We report the row as published and flag the transposition rather than quietly rewriting a public record.
Is Colombia still an option?
Yes. bioaccess® still runs trials in Colombia. A Monterrey search is not an instruction to abandon INVIMA. See CRO in Colombia.
Leave a Reply