NCT07355270

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Aqua Medical, Inc. · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The main aims of the study are : Evaluate the safety of the device and procedure based on the reported adverse events that occur. Evaluate device tolerability based on pain scores reported by patients. Evaluate the effectiveness of the device and procedure by comparing change in HbA1c from baseline to 168 days post procedure. The subject population for this study are adults (22-65 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, Pre-procedure tests, RF Vapor ablation procedure, and Post-vapor ablation follow-up (up to 168 days).

Conditions

• Type-2 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	RF Vapor Ablation	RF Vapor ablation of the proximal intestinal mucosa

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study