NCT06724822

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (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 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.

Detailed description

The aims of the study are: 1. Evaluate the safety of the device and retreatment procedure based on the reported adverse events that occur. 2. Evaluate the effectiveness of the device and procedure by comparing change in HbA1c from baseline to 168 days post retreatment procedure. 3. Evaluate device tolerability based on pain scores reported by patients. The subject population for this study are adults (18-65 years of age) with type-2 diabetes mellitus who have received initial RF vapor ablation of the duodenal mucosa and had improvement in HbA1C of \<0.5% at their six month evaluation. Twelve subjects, previously enrolled in the STEAM T2DM Pilot study did not show adequate (\>0.5%) response to initial RF vapor ablation treatment of the duodenal mucosa. Minimum study duration per subject is 6 months. The study comprises of 5 phases: Screening, Pre-procedure tests, RF Vapor ablation procedure, Post vapor ablation follow up, identification and long term follow up of responders.

Conditions

• Diabetes Mellitus, Type 2

Interventions

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

Timeline

• Start date: 2024-11-14
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2024-12-09
• Last updated: 2025-11-06

Locations

1 site across 1 country: Chile

Regulatory

• FDA-regulated device study