Actively Recruiting
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)
Led by Aqua Medical, Inc. · Updated on 2026-04-30
20
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and non-pregnant women 22-65 years of age
- Diagnosed with type 2 diabetes mellitus for at least 1 year and no more than 15 years
- HbA1c between 7.5% and 10% (58-86 mmol/mol)
- Body mass index (BMI) between 24 and 40 kg/m2
- Taking one or more non-insulin glucose-lowering medications with stable doses for at least 12 weeks prior to screening
- Willing to reduce sulfonylurea dose to 50% if applicable during run-in phase
- Agree to use additional glucose-lowering treatment if recommended
- Weight stable (less than 5% change) in the 12 weeks prior to screening
- Women of childbearing potential must use at least one acceptable method of contraception throughout the study
- Willing and able to use continuous glucose monitoring (CGM) during the study
- Able to comply with study requirements and sign informed consent
You will not qualify if you...
- Diagnosis of type 1 diabetes
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- Probable insulin production failure (serum C-peptide 0.3-0.6 nmol/l)
- Use of insulin for more than 1 month in the last 2 years (except gestational diabetes treatment)
- Impaired hypoglycemia awareness or history of severe hypoglycemia events
- Untreated or unstable microvascular complications of diabetes unless stable and treated for 3 months
- Uncontrolled systemic autoimmune diseases or requiring steroids/biologics
- Previous gastrointestinal surgeries limiting duodenal access (except certain sleeve gastrectomies)
- History of pancreatitis or diabetic gastroparesis
- Active liver disease excluding NASH and NAFLD
- Recent gastrointestinal illness or symptomatic gallstones
- Severe irritable bowel syndrome or inflammatory bowel disease
- Alcoholic liver disease or alcohol use disorder
- Structural or functional esophageal disorders increasing endoscopy risk
- Current use of anticoagulants or antiplatelet drugs that cannot be safely stopped
- Inability to discontinue high-dose NSAIDs around procedure
- Recent systemic glucocorticoid use
- Persistent anemia or known hemoglobinopathy
- Recent blood donation or transfusion
- Significant cardiovascular disease or uncontrolled hypertension
- Reduced kidney function (eGFR ≤ 45 ml/min/1.73m2)
- Immunocompromised status
- Uncontrolled hypothyroidism
- Unsuitable for endoscopy or anesthesia
- Active illicit substance abuse
- Active malignancy within past 5 years (except non-melanoma skin cancer)
- Currently breastfeeding
- Participation in another investigational trial
- Other conditions or factors deemed unsuitable by investigator
- Life expectancy less than 3 years
- Use of cardiac pacemaker, implantable cardioverter-defibrillator, or similar devices
- Contraindications to sedation, anesthesia, or upper GI endoscopy including high anesthetic risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Mayo Clinic
Scottsdale, Arizona, United States, 85054
Actively Recruiting
2
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
4
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
K
Krithika Rupnarayan, MD, MPH
CONTACT
A
Alina Stoica
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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