NCT04419779

Evaluation of the Efficacy and Safety of DMR Using the Revita® in Subjects With Inadequately Controlled Type 2 Diabetes

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 With Inadequate Glycemic Control

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Fractyl Health Inc. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The Revita® system is being investigated to assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2 Diabetes who are inadequately controlled on one or more glucose lowering agents. The purpose of this study is to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over to receive the DMR treatment at 48 weeks and will be followed per protocol for 48 weeks post treatment.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-03-08
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2020-06-05
• Last updated: 2025-11-13

Locations

58 sites across 7 countries: United States, Belgium, Ireland, Italy, Netherlands, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study