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ACTIVE NOT RECRUITING
NCT06724822
NA

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

Sponsor: Aqua Medical, Inc.

View on ClinicalTrials.gov

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.

Official title: A Pilot Human Investigation of the Safety, Tolerability, Effectiveness of the Aqua Medical Circumferential RF Vapor (RFV) Ablation System for Duodenal Mucosal Repeat Ablation Treatment for the Management of Type-2 Diabetes Mellitus (STEAM T-2 DM Retreatment Study) in Patients Who Were Non-Responders to Initial Duodenal Mucosal Ablation Treatment

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-11-14

Completion Date

2027-06-30

Last Updated

2025-11-06

Healthy Volunteers

No

Interventions

DEVICE

RF Vapor Ablation

RF Vapor ablation of the duodenum

Locations (1)

Clinica Colonial

Santiago, Chile