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)
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Aqua Medical, Inc.
- Study ID
- NCT07355270
- Status
- Recruiting
Conditions
- Type-2 Diabetes Mellitus
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- RF Vapor Ablation — DEVICERF Vapor ablation of the proximal intestinal mucosa
Study Details
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).
Key Dates
- Start date
- Apr 1, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2026
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Study arm- RF Vapor Ablation arm (PIMA arm)This is a single arm study. All enrolled patients will be included in this arm
Primary Outcome Measure
Safety endpoint [ Time Frame: 6 months ]
Central Contacts
- Krithika Rupnarayan, MD, MPH925-223-6392
- Alina Stoica
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | James Swain, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Scottsdale | Arizona | 85054 | Rahul Pannala, MD (PRINCIPAL_INVESTIGATOR) |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | Jennifer Phan, MD (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina School of Medicine | Chapel Hill | North Carolina | 27599 | Nicholas J Shaheen, MD, MPH (PRINCIPAL_INVESTIGATOR) |