Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy (REVITALIZE 1)
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|ClinicalTrials.gov Identifier: NCT04419779|
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : May 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Device: Duodenal Mucosal Resurfacing (DMR) Device: Duodenal Mucosal Resurfacing (Sham)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||560 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy|
|Actual Study Start Date :||March 8, 2021|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||January 2025|
Active Comparator: Duodenal Mucosal Resurfacing (DMR)
Duodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal muscosa in an upper endoscopic procedure in patients with type 2 diabetes on insulin.
Device: Duodenal Mucosal Resurfacing (DMR)
The Fractyl DMR Procedure utilizes the Revita® Catheter to perform hydrothermal ablation of the duodenum. The Catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DMR treatment are followed for 48 weeks post treatment.
Sham Comparator: Duodenal Mucosal Resurfacing Sham (Sham)
Duodenal Mucosal Resurfacing Sham (Sham) treatment will include an upper endoscopic procedure similar to DMR treatment without hydrothermal ablation of the duodenal mucosa in patients with type 2 diabetes on insulin.
Device: Duodenal Mucosal Resurfacing (Sham)
The Sham procedure consists of placing the Revita® Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient. Subjects who receive the Sham procedure are followed for 48 weeks post treatment and are offered cross over to undergo the DMR procedure at 48 weeks and are followed for further 48 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.
- The primary endpoint is the percentage of subjects at Week 24 who achieve a HbA1c of </= 7.0% without the need for insulin, DMR vs Sham [ Time Frame: 24 Weeks ]The primary endpoint will be analyzed using a logistic regression model with terms for baseline insulin dose, baseline HbA1c, change from screening to baseline HbA1c, region (e.g. USA, OUS), baseline FPG, and treatment group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419779
|Contact: Sarah Hackettfirstname.lastname@example.org|
|Contact: Christine Delanoemail@example.com|