A U.S. Pilot Human Investigation of RadiofrEquency Vapor Ablation System to Evaluate Safety, TOle… (NCT07355270) | Clinical Trial Compass
RecruitingNot Applicable
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)
United States20 participantsStarted 2026-04-01
Plain-language 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).
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
✓. Men and non-pregnant women 22-65 years of age
✓. Diagnosed with T2DM for at least 1 year and less than or equal to 15 years
✓. HbA1C of 7.5 - 10% (58-86 mmol/mol)
✓. BMI ≥ 24 and ≤ 40 kg/m2
✓. 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.
✓. 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.
✓. Weight stability (defined as a \< 5% change in body weight) in the 12 weeks prior to the screening visit. Participants should agree to refrain from using over the counter or herbal supplements intended for weight loss. Participants already on a prescribed weight loss drug should agree to not further titrate their medications during the study.
✓. Women of childbearing potential must be using at least one acceptable method of contraception throughout the study
Exclusion criteria
✕. Diagnosis of Type-1 Diabetes
✕. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
✕. Probable insulin production failure, defined as serum C-peptide of 0.3-0.6 nmol/l.
✕. 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.
✕. Hypoglycemia unawareness as defined by a score of 4 or higher on a Gold score questionnaire suggestive of impaired awareness of hypoglycemia (IAH).
✕. 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).
✕. 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.
✕. 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).