Names and roles cited from ClinicalTrials.gov study records NCT02709577, NCT05887635, and NCT06724822 (OverallOfficial and location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. Dual Clínica Colonial / Clínica MEDS La Dehesa affiliation is an operator fact confirmed by bioaccess® leadership on 24 September 2026; it is not a ClinicalTrials.gov MEDS PI or CONTACT row. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or a MEDS NCT investigator string.
If you searched Leonardo Rodriguez Grunert MD first-in-human, Leonardo Rodríguez Grunert Chile clinical trial, Dr Rodriguez Colonial Chile CRO, Leonardo Rodriguez MEDS La Dehesa, EndoBarrier Chile PI, duodenal RF vapor ablation Chile investigator, or “go direct Leonardo Rodriguez Grunert,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. Public registry strings include Leonardo Rodriguez Grunert, MD and Leonardo Rodriguez, MD — the same person; this page uses Grunert in the title and notes the ClinicalTrials.gov alias. The public posture visible on those rows is digestive / metabolic / endoscopic device investigation. A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP file.
bioaccess®’s position is simple and it is not adversarial: the investigator / site contact is part of the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email a named NCT contact still have to rebuild that stack. An NCT contact or OverallOfficial field is not a CRO.
This page intercepts the Rodríguez Grunert search. Matching facility intercepts (do not merge): Clínica Colonial Santiago and Clínica MEDS La Dehesa Santiago. Dual affiliation (Clínica Colonial and Clínica MEDS La Dehesa) is confirmed as an operator fact. Cite Colonial / Hospital Dipreca roles from ClinicalTrials.gov only. Do not invent a Clínica MEDS La Dehesa NCT PI or CONTACT row — none appears on the public MEDS location contacts cited for that campus today.
Why the MD name wins the search — and why that is not a CRO
Registries often surface investigator and site-contact names next to a facility. Sponsors searching those names land on people, not operators. Public facts we cite:
- Name: Leonardo Rodríguez Grunert, MD (ClinicalTrials.gov also lists Leonardo Rodriguez, MD).
- NCT02709577 — COMPLETED DEVICE row; OverallOfficial PRINCIPAL_INVESTIGATOR “Leonardo Rodriguez Grunert, MD” / Hospital Dipreca (GI Sleeve / EndoBarrier type 2 diabetes program on the public brief title).
- NCT05887635 — RECRUITING DEVICE row; location CONTACT “Leonardo Rodriguez, MD” / Clinica Colonial, Santiago, Chile (duodenal mucosal RF vapor ablation).
- NCT06724822 — ACTIVE_NOT_RECRUITING DEVICE row; OverallOfficial PRINCIPAL_INVESTIGATOR “Leonardo Rodriguez, MD” / Clinica Colonial, Santiago, Chile (RF vapor retreatment).
- Affiliations on this intercept: Clínica Colonial (Santiago) from the public NCT rows above; Clínica MEDS La Dehesa as dual affiliation per operator confirmation — not as an invented MEDS NCT PI string.
We cite those public fields only. We do not reprint personal email or phone from the NCT onto this page. We do not invent specialty board certifications. Emailing a named contact confirms interest. It does not open ISP.
The contact is the contact. The CRO is the operator.
What a named PI or site contact can typically do when a sponsor “goes direct”:
- Discuss clinical interest and whether a protocol fits their digestive / metabolic / endoscopic device service line.
- Point toward institutional ethics calendars and campus research rules at Colonial or MEDS when they practice there.
- Help estimate local visit and procedure effort for cases they will run.
What a named contact is not built to own for an investigational device:
- ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named MD is not that stack.
- Investigational import end-to-end (see importer of record for clinical trial devices in Latin America).
- Clinical trial insurance, ISO 14155 monitoring, EDC, SAE reporting, TMF, and the 21 CFR 812.28 package.
- Multi-country optionality if the indication later needs another Latin American country.
Going direct to an MD name on ClinicalTrials.gov is how you find a person. It is not how you open an investigational file.
How ISP actually works (the short version)
Use clinical-trials-chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.
Ask for a protocol-specific calendar. A PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact work.
All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.
Do not smear the investigator
Leonardo Rodríguez Grunert, MD, is a named public NCT principal investigator and site contact on serious DEVICE rows spanning Hospital Dipreca and Clínica Colonial. Dual practice at Clínica MEDS La Dehesa is an operator fact, not a smear. That is evidence of a person on Santiago campuses, not a punchline. Cite the name. Hire the operator. Activate a campus only if it fits.
Colombia is still on the map
Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
Frequently asked questions
Can I email Leonardo Rodríguez Grunert, MD directly for a device FIH?
You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.
Did bioaccess® run NCT02709577, NCT05887635, or NCT06724822?
No. We cite the public OverallOfficial and location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.
Is Rodríguez Grunert only Clínica Colonial?
ClinicalTrials.gov cites Hospital Dipreca (NCT02709577 OverallOfficial) and Clínica Colonial (NCT05887635 CONTACT; NCT06724822 OverallOfficial). Dual affiliation with Clínica MEDS La Dehesa is an operator fact confirmed 24 September 2026. Do not invent a MEDS NCT PI or CONTACT row on this page.
Is this the same intercept as Clínica Colonial or Clínica MEDS La Dehesa?
No. Those are facility intercepts. This page is the named PI / site-contact intercept. Keep the three pages distinct: clinica-colonial-santiago-fih, clinica-meds-dehesa-santiago-fih, and this slug.
Next step
If the search that brought you here was this MD name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility siblings: Clínica Colonial Santiago and Clínica MEDS La Dehesa Santiago.
Julio G. Martinez-Clark, CEO · bioaccess®
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