RecruitingType-2 Diabetes Mellitus
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)
Eligible age
22–65 yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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).
Sponsor: Aqua Medical, Inc.
You may qualify if…
- ✓ 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 reduction to ≤50% of the maximum labeled dose during the run-in phase. This adjustment is intended solely to minimize the risk of hypoglycemia during intensive monitoring and dietary standardization and will not be considered a therapeutic change for purposes of eligibility. Subjects unwilling to comply with this dose reduction will be excluded.
- ✓ Note 2: GLP-1s are considered non-insulin glucose lowering medications.
- ✓ 6. Agrees to use an additional glucose-lowering treatment (e.g., liraglutide, other OAD except for glyburide), if recommended by the study Investigator in case of persistent hyperglycemia.
You may not qualify if…
- ✕ 1. Diagnosis of Type-1 Diabetes
- ✕ 2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
- ✕ 3. Probable insulin production failure, defined as serum C-peptide of 0.3-0.6 nmol/l.
- ✕ 4. Current or previous use of any types of insulin for \>1 month (at any time, except for treatment of gestational diabetes) in the last 2 years.
- ✕ 5. Hypoglycemia unawareness as defined by a score of 4 or higher on a Gold score questionnaire suggestive of impaired awareness of hypoglycemia (IAH).
- ✕ 6. History of severe hypoglycemia (2 or more severe hypoglycemic event, as defined by need for third-party assistance, in the last 6 months from the screening visit).
- ✕ 7. Subjects with untreated or unstable microvascular complications of diabetes such as retinopathy, nephropathy, and neuropathy. Subjects who have been appropriately treated/monitored and stable for the prior 3 months before study participation can be included as determined as safe and reasonable by the study PI.
- ✕ 8. Known systemic autoimmune disease that is uncontrolled or requiring steroids or biologics, including a positive anti-glutamic acid decarboxylase (GAD) test. Systemic autoimmune diseases include but not limited to celiac disease, duodenal Crohn disease or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other systemic autoimmune connective tissue disorder. (Participants with adequately controlled primary hypothyroidism or with mild to moderate psoriasis managed with topical therapy-affecting less than 10% of body surface area and not involving special areas (e.g., face, palms)-may be included).
Where it's recruiting
Source: ClinicalTrials.gov · NCT07355270 · last updated 2026-04-30