NCT05887635

Study of Duodenal Mucosal RF Vapor Ablation in Subjects With Type-2 Diabetes Mellitus

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Aqua Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to test the hypothesis that RF vapor ablation of the duodenal mucosa will result in improvement in glycemic parameters, without complications (bleeding/ stricture / perforation). The main aims of the study are : 1. Evaluate the safety of the device and 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 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. Study participation is 6 months for each patient. The study is comprised of 5 phases: Screening, Run-in, RF Vapor ablation procedure, and Post-vapor ablation follow-up (up to 168 days), 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: 2023-09-02
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2023-06-05
• Last updated: 2024-10-24

Locations

1 site across 1 country: Chile

Regulatory

• FDA-regulated device study