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)
Aqua Medical, Inc.
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).
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-vap…
Eligibility
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Men and non-pregnant women 22-65 years of age 2. Diagnosed with T2DM for at least 1 year and less than or equal to 15 years 3. HbA1C of 7.5 - 10% (58-86 mmol/mol) 4. BMI ≥ 24 and ≤ 40 kg/m2 5. On one or more non-insulin glucose-lowering medications, with no therapeutic changes in medication regimen for at least 12 weeks prior to the screening visit, to ensure stable glycemic control. Note 1: Exception for sulfonylureas (SU): For safety reasons, subjects taking sulfonylureas (limited to glipizide or glimepiride only) will be required to undergo a protocol-mandated re…
Interventions
- DeviceRF Vapor Ablation
RF Vapor ablation of the proximal intestinal mucosa
Locations (4)
- Mayo ClinicScottsdale, Arizona
- HonorHealth Research InstituteScottsdale, Arizona
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- University of North Carolina School of MedicineChapel Hill, North Carolina