RF Vapor Ablation for Diabetes

(RESTORE-1 Trial)

Not yet recruiting at 1 trial location

Overseen By Alina Stoica

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aqua Medical, Inc.

Must be taking: Non-insulin glucose-lowering

Must not be taking: Insulin, Anticoagulants, P2Y12 inhibitors, NSAIDs

Disqualifiers: Type-1 diabetes, Insulin use, Severe hypoglycemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Nicholas Shaheen, MD

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

This trial is for U.S. adults aged 22-65 with Type 2 Diabetes Mellitus (T2DM) diagnosed between 1 and 15 years, having an HbA1C of 7.5 -10% and a BMI of ≥24 & ≤40 kg/m2. They must be on stable glucose-lowering meds without changes for the past 12 weeks, except sulfonylureas which require dose reduction. Weight should be stable, no weight loss supplements are allowed, and women must use contraception.

Inclusion Criteria

I've been on stable diabetes medication for at least 12 weeks.

I am willing to lower my dose of glipizide or glimepiride if I'm taking it.

I am aware GLP-1s are not insulin but are used to lower blood sugar.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants undergo a run-in period to stabilize their condition before the procedure

2 weeks

Pre-procedure tests

Participants undergo tests to prepare for the RF vapor ablation procedure

1 week

RF Vapor ablation procedure

Participants receive the RF vapor ablation treatment

1 day

Post-vapor ablation follow-up

Participants are monitored for safety, tolerability, and effectiveness of the procedure

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RF Vapor Ablation

Trial Overview

The RESTORE-1 study tests RF vapor ablation's safety and effectiveness in improving blood sugar control in T2DM patients by ablating proximal intestinal mucosa. It aims to show glycemic improvement without serious or unexpected adverse effects from the device used.

How Is the Trial Designed?

Group I: Study arm- RF Vapor Ablation arm (PIMA arm) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Aqua Medical, Inc.

Lead Sponsor

Trials

3

Recruited

70+