NCT02879383

Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)

Evaluation of the Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Fractyl Health Inc. · Industry
• Sex: All
• Age: 28 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the efficacy and safety of the Fractyl duodenal mucosal resurfacing (DMR) Procedure using the Revita System compared to a sham procedure for the treatment of uncontrolled type 2 diabetes. Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. The Sham treatment arm will cross over to receive the DMR treatment at 24 weeks with background medications held constant from 24-48 weeks of follow up.

Detailed description

The study is a multi-center, randomized, prospective, double-blinded (subject and endocrinologist) trial of type 2 diabetes patients sub-optimally controlled on 1 or more oral anti-diabetic medications comparing the Fractyl DMR procedure to sham procedure. Randomization will be 1:1 DMR treatment to sham. All subjects will participate in a 4 week oral anti-diabetic medication run-in period before the index procedure to confirm lack of blood glucose control in conjunction with medication compliance and nutritional counseling. The Sham treatment arm will cross-over to receive the DMR treatment at 24 weeks with background medications held constant 24weeks of follow up after the cross-over DMR procedure. The DMR treatment arm will be managed according to current diabetes standard of care. Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. The Sham treatment arm will cross over to receive the DMR treatment at 24 weeks with background medications held constant from 24-48 weeks of follow up.

Conditions

• Diabetes Mellitus, Type 2
• Noninsulin-Dependent Diabetes Mellitus

Interventions

Type	Name	Description
PROCEDURE	DMR Procedure	The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
PROCEDURE	Sham Procedure	The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2016-08-25
• Last updated: 2024-02-14
• Results posted: 2021-05-25

Locations

11 sites across 5 countries: Belgium, Brazil, Italy, Netherlands, United Kingdom