RESTORE-1 Study: RF Vapor Ablation for Type 2 Diabetes

This study is testing a new procedure called RF Vapor Ablation of the proximal intestinal mucosa to see if it's safe, tolerable, and effective for people with Type 2 Diabetes. This procedure uses radiofrequency vapor to treat the lining of the upper part of the small intestine. Researchers want to see if this treatment can improve blood sugar levels (measured by HbA1c) without causing serious side effects or unexpected problems with the device. You might be able to join if you are 22-65 years old, have Type 2 Diabetes for 1-15 years, and your HbA1c is between 7.5% and 10%. The study is currently unclear about its recruitment status.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is a pilot human investigation, meaning it's an early study to gather initial information.
What's involved
Your participation would involve a screening phase, a run-in phase, pre-procedure tests, the RF Vapor ablation procedure, and follow-up visits for up to 168 days.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for 6 months after the procedure to check safety and effectiveness, and for 14 days to check tolerability.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07355270

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)

Recruiting
NAAges 22–65InterventionalTreatment
Aqua Medical, Inc.
~20 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:RF Vapor Ablation

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety endpoint
Measured over 6 months
+2 more outcomes measured
Type-2 Diabetes Mellitus
4 sites across 3 states
Arizona2
California1
North Carolina1
  • Nicholas Shaheen, MD · PRINCIPAL_INVESTIGATOR · University of North Carolina

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  • Safety endpoint6 months

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

  • Tolerability endpoint14 days

    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.)

  • Efficacy endpoint6 months

    Change in HbA1c from baseline to 6 months post procedure