Clinical Trial

A U.S. Pilot Human Investigation of RadiofrEquency Vapor Ablation System to Evaluate Safety, TOleRability, and Effectiveness for Proximal Intestinal Mucosal Ablation in Patients With Type 2 Diabetes Mellitus (RESTORE-1 Study)

Study acronym: RESTORE-1
Recruiting
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Summary
The purpose of this study is to assess the safety, tolerability and effectiveness of RF vapor ablation of the proximal intestinal mucosa. This study will test the hypothesis that RF vapor ablation will result in improvement in glycemic parameters, without Serious Adverse Events (SAE) or Unanticipated Adverse Device Effects (UADE).
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-01
Trial Details
NCT Number NCT07355270
Lead Sponsor Aqua Medical, Inc.
Conditions Type-2 Diabetes Mellitus
Enrollment 20 participants
Start Date 2026-04-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-30