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) (RESTORE-1)
Sponsor: Aqua Medical, Inc.
Listed as NCT07355270, this observational or N/A phase trial focuses on Type-2 Diabetes Mellitus and remains actively recruiting participants. Sponsored by Aqua Medical, Inc., it has been updated 2 times since 2026, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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).
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).
Status Flow
Change History
2 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Status: Not Yet Recruiting → Recruiting · Phase: NA → None
-
Feb 2026 — May 2026 [monthly]
Not Yet Recruiting NA
First recorded
Eligibility 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).
Contact Information
- Aqua Medical, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .