NCT06655740

Safety, Tolerability, and Effectiveness of Duodenal Mucosal RF Vapor Ablation for Insulin Elimination in Type-2 Diabetes

A Pilot Human Study of the Safety, Tolerability and Effectiveness of the Aqua Medical Circumferential RF Vapor (RFV) Ablation System for Duodenal Mucosal Ablation for the Management of Insulin Requiring Type-2 Diabetes Mellitus

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Aqua Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether RFVA of the duodenal mucosa with or without the combination of Semaglutide is a safe and effective treatment to remove the need for insulin therapy among patients with T2D who are on stable doses of insulin.

Detailed description

This is a prospective, open-label pilot, to determine safety and efficacy of step-up therapy with RFVA and Semaglutide

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	RF Vapor Ablation	RF Vapor ablation of the duodenum

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-06-30
• Completion: 2027-07-31
• First posted: 2024-10-23
• Last updated: 2025-11-10

Locations

1 site across 1 country: Chile

Regulatory

• FDA-regulated device study