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RF Vapor Ablation Retreatment of Duodenal Mucosa in Non-responders With Type-2 Diabetes Mellitus

NCT06724822 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-11-06

No results posted yet for this study

Summary

The purpose of this study is to test the hypothesis that re-treatment of the duodenal mucosa with RF vapor ablation will result in improvement in glycemic parameters, without complications (bleeding/ stricture / perforation) among subjects who failed to show improvement after initial treatment of the duodenal mucosa with RF vapor ablation.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DEVICE

RF Vapor Ablation

RF Vapor ablation of the duodenum

Sponsors & Collaborators

  • Aqua Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Leonardo Rodriguez, MD · Clinica Colonial, Santiago, Chile

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-14
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06724822 on ClinicalTrials.gov