Clinical Trial

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

Study acronym: STEAM T-2DM
Recruiting
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Record status
This record was last updated October 24, 2024 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-05-31; most recent amendment 2024-10-22.
Status change: Active, Not Recruiting → Recruiting 2024-10-21
Status change: Not Yet Recruiting → Active, Not Recruiting 2024-01-30
Trial Details
NCT Number NCT05887635
Lead Sponsor Aqua Medical, Inc.
Conditions Diabetes Mellitus Type 2
Enrollment 40 participants
Start Date 2023-09-02
Primary Completion 2026-01 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2024-10-24