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)

NCT07355270 | Recruiting DMC FDA Device

• 1 other identifier: CLD-1021-US
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Type-2 Diabetes Mellitus

Keywords

RESTORE-1; Type-2 Diabetes Mellitus; T2DM; Diabetes

Outcome Measures

Primary Outcomes (3)

• Safety endpoint

  Number of subjects with reported device or procedure related SAEs or UADEs.

  6 months

• Tolerability endpoint

  Descriptive statistics on Visual Analogue Scale(VAS) pain scores (A Visual Analog Scale (VAS) pain score is a patient's self-reported measure of pain intensity, marked on a straight line scale from 0-10, with "no pain" at the zero-end and "worst imaginable pain" at 10.)

  14 days

• Efficacy endpoint

  Change in HbA1c from baseline to 6 months post procedure

  6 months

Secondary Outcomes (6)

• Change in HbA1c at 3 months post procedure

  3 months

• Change in FPG from baseline to 3 months and 6 months post procedure

  6 months

• Proportion of ablation-treated subjects with an HbA1c improvement > 0.5% from baseline at 6 months.

  6 months

• Change in HOMA-IR from baseline to 6 months post procedure.

  6 months

• Change in UACR from baseline to 6 months post procedure.

  6 months

Study Arms (1)

Study arm- RF Vapor Ablation arm (PIMA arm)

EXPERIMENTAL

This is a single arm study. All enrolled patients will be included in this arm

Device: RF Vapor Ablation

Interventions

RF Vapor Ablation DEVICE

RF Vapor ablation of the proximal intestinal mucosa

Also known as: Aqua Medical RF Vapor System

Study arm- RF Vapor Ablation arm (PIMA arm)

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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
• Willing and able to use CGM for the duration of the study and comply with study visits and study tasks as required per protocol.
• Able to comply with study requirements and understand and sign the Informed Consent Form

You may not qualify if:

• 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).
• Previous GI surgery that could limit access to the duodenum such as Billroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions. (Patients who have undergone a laparoscopic sleeve gastrectomy (LSG) or an endoscopic sleeve gastrectomy (ESG) procedure more than one year prior to enrollment will not be excluded from participation in this study.)
• History of chronic pancreatitis or a diagnosis of idiopathic acute pancreatitis within the past 12 months.
• Documented history of diabetic gastroparesis confirmed by gastric emptying study.
• Known active hepatitis or liver disease, excluding nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD).
• Symptomatic gallstones, or acute gastrointestinal illness in the previous 7 days.
• Known history of severe irritable bowel syndrome, radiation enteritis or other inflammatory bowel syndrome, such as Crohn's disease and Celiac disease.
• Alcoholic liver disease, as indicated by ANI\>-0.66 and AUDIT-C questionnaire

Sponsors & Collaborators

• Aqua Medical, Inc.: lead

Study Sites (4)

Mayo Clinic

Scottsdale, Arizona, 85054, United States

RECRUITING

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

RECRUITING

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nicholas Shaheen, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krithika Rupnarayan, MD, MPH

CONTACT

925-223-6392; krupnarayan@aquaendoscopy.com

Alina Stoica

CONTACT

astoica@aquaendoscopy.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, prospective

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)