RF Vapor Ablation for Diabetes
(RESTORE-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called RF vapor ablation, which targets the lining of the upper part of the small intestine. The researchers aim to determine if this procedure can improve blood sugar levels in people with Type 2 Diabetes without causing serious side effects. It is intended for individuals who have had Type 2 Diabetes for at least a year, struggle to manage blood sugar levels with oral medications, and have a Body Mass Index (BMI) between 24 and 40. Participants must maintain stable weight and medication and be willing to use a continuous glucose monitor. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatments for Type 2 Diabetes.
Will I have to stop taking my current medications?
You may need to adjust your current medications. If you're taking sulfonylureas like glipizide or glimepiride, you'll need to reduce the dose to 50% of the maximum during the study. Other medications may need to be adjusted if recommended by the study investigator.
What prior data suggests that RF vapor ablation is safe for diabetes treatment?
Research has shown that RF vapor ablation, which uses heat to target specific tissue, is generally safe and well-tolerated. In one study, all patients successfully completed the treatment. Another study found it safe and easy to perform for individuals with poorly controlled type 2 diabetes, yielding good early results.
Experts noted that using a dose of 200 joules or less was safe, with no serious impact on deeper muscle layers. This suggests the treatment usually does not harm deeper tissues. Overall, RF vapor ablation appears to be a promising and safe option based on current research findings.12345Why are researchers excited about this trial?
RF Vapor Ablation is unique because it uses radiofrequency energy to target and disrupt specific nerve pathways that influence blood sugar regulation in diabetes. Unlike traditional treatments like insulin injections or oral medications that manage blood sugar levels, this technique offers a novel approach by potentially altering the body's internal mechanisms. Researchers are excited about this method because it could lead to more sustained blood sugar control and reduce the need for continuous medication.
What evidence suggests that RF vapor ablation is effective for diabetes?
Research has shown that RF vapor ablation, the treatment under study in this trial, can help control blood sugar in people with type 2 diabetes. Studies have found it to be safe and well-tolerated, with excellent early results for those with poorly controlled diabetes. The procedure targets the lining of a part of the small intestine, which may help the body manage sugar better. In past studies, all patients successfully completed the procedure. These findings suggest that RF vapor ablation could be a promising method for managing diabetes.23467
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants undergo a run-in period to stabilize their condition before the procedure
Pre-procedure tests
Participants undergo tests to prepare for the RF vapor ablation procedure
RF Vapor ablation procedure
Participants receive the RF vapor ablation treatment
Post-vapor ablation follow-up
Participants are monitored for safety, tolerability, and effectiveness of the procedure
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?
1
Treatment groups
Experimental Treatment
This is a single arm study. All enrolled patients will be included in this arm
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aqua Medical, Inc.
Lead Sponsor
Citations
Radiofrequency vapor ablation for duodenal mucosal ...
The overall technical success rate was 100%. Among the 25 patients receiving a treatment dose (double application), the mean procedure time was 49.7 minutes (SD ...
Radiofrequency vapor ablation for duodenal mucosal ...
Radiofrequency vapor ablation for duodenal mucosal ablation in the treatment of type 2 diabetes: results from the first-in-human pilot study.
3.
journals.lww.com
journals.lww.com/ajg/fulltext/2024/10001/s1537_radiofrequency_vapor_ablation_is_safe_and.1538.aspxS1537 Radiofrequency Vapor Ablation is Safe and Well- ...
DA using RFVA is safe, well tolerated, and easy to perform for the management of poorly controlled T2D with excellent early efficacy.
NCT05887635 | Study of Duodenal Mucosal RF Vapor ...
The purpose of this clinical study is to test the hypothesis that RF vapor ablation of the duodenal mucosa will result in improvement in glycemic parameters ...
P171 Evaluation of the safety and utility of radiofrequency ...
Vapor ablation using the RFVA system at a dose ≤200J can be safely applied for DA. Clinically significant muscularis involvement was only encountered at 400J.
Radiofrequency vapor ablation for duodenal mucosal ...
The overall technical success rate was 100%. Among the 25 patients receiving a treatment dose (double application), the mean procedure time was 49.7 minutes (SD ...
RF Vapor Ablation Retreatment of Duodenal Mucosa in ...
The purpose of this study is to test the hypothesis that re-treatment of the duodenal mucosa with RF vapor ablation will result in improvement in glycemic ...
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