Figures cited from the live ClinicalTrials.gov record NCT07681154 (first posted 2 July 2026; last update posted 6 November 2026) and MassDevice coverage of Flow Medical dated 1 November 2026, verified 6 November 2026. General information, not legal or regulatory advice. Confirm current ISP, Law 20.120 ethics, and FDA rules with qualified advisers. We name only the investigator, affiliation, and trial those sources support. Flow Medical Solutions, Inc. is not claimed as a bioaccess® client.
If you searched Miguel Naranjo Flow Medical, Dr. Miguel Naranjo Talca, Miguel Naranjo first-in-human Chile, or Hospital Regional de Talca principal investigator, you found a real investigator in the public record. Miguel Naranjo, MD, is named on ClinicalTrials.gov as principal investigator and overall official for the Flow Medical Solutions PE catheter pilot at Hospital Regional de Talca. A principal investigator is not the CRO.
bioaccess®’s position is simple and it is not adversarial: the investigator and the site run the cases. The First-in-Human CRO still owns ISP authorization, Law 20.120 Ethical-Scientific Committee review, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Emailing the PI is a good way to test investigator interest. It is not a regulatory plan.
The facility-level intercept is here: Hospital Regional de Talca: the site is not the CRO. Chile country path: Chile ISP clinical trial for medical devices.
What the public record says
- NCT07681154: industry sponsor Flow Medical Solutions, Inc.; interventional safety-and-feasibility pilot of the Flow Medical Catheter for catheter-directed thrombolysis in acute intermediate-risk pulmonary embolism; estimated enrollment 20; status NOT_YET_RECRUITING on the 6 November 2026 update; single location Hospital Regional de Talca (HRT), Talca, Chile; no collaborator; no CRO listed.
- Overall official / principal investigator on that record: Miguel Naranjo, MD, affiliation Hospital Regional de Talca. Sub-investigator Fatima Prada, MD, also named on the location row.
- MassDevice, 1 November 2026: Flow Medical raised $6 million and expects a first-in-human case “very soon” for the HELYX-PE System, with a 2027 IDE plan. The press piece does not name Dr. Naranjo; the NCT does.
PI versus CRO
| Workstream | Principal investigator | First-in-Human CRO |
|---|---|---|
| Clinical judgment and cases | Yes | Supports with protocol training and monitoring |
| ISP file and amendments | Signs what the site must sign | Prepares, submits, and answers deficiencies |
| Device import | No | Importer of record for the investigational device |
| ISO 14155 monitoring and TMF | Keeps source documents | Monitors, reconciles, and closes out |
| FDA 21 CFR 812.28 | Provides site data | Builds the foreign-data narrative for the U.S. submission |
| Country optionality | One investigator at one Chile hospital | Colombia, Panama, and the rest of the platform if Talca is not enough |
Do not smear the investigator
Dr. Miguel Naranjo is a named public-record principal investigator on an industry PE device pilot. This page is not a critique of the PI. A public NCT row is a signal that an investigator was selected. It is not a substitute for a CRO quality system. Work with the investigator. Hire the operator.
Colombia is still on the map
bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 6 November 2026). Always bioaccess®. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.
FAQ
Did bioaccess® work on Dr. Naranjo’s Flow Medical study?
No. This page reports public sources only and claims no role in that study. NCT07681154 does not name a CRO.
Can I email the PI and skip the CRO?
You can test investigator interest. You cannot, by emailing the PI, become ISP-authorized, import the investigational catheter, insure the trial, monitor under ISO 14155, or assemble a 21 CFR 812.28 package. Contract the CRO, then activate Hospital Regional de Talca with Dr. Naranjo if the protocol fits.
Does bioaccess® only work in Chile?
No. bioaccess® is the First-in-Human CRO for medical devices in Latin America since 2010, and it still runs clinical trials in Colombia as well as Chile, Panama, and the rest of the platform.
Next step
Start as the operator: contact bioaccess® or First-in-Human CRO. Facility page: Hospital Regional de Talca. Chile: ISP path. Hub: ClinicalTrials.gov FIH sites vs the CRO.