Summary

Eligibility
for people ages 21-70 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Adarsh Thaker (ucla)

Description

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.

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 With Inadequate Glycemic Control

Keywords

Type 2 Diabetes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Revita System, Duodenal Mucosal Resurfacing, Insulin-Dependent Diabetes Mellitus, Type 2 Diabetes Mellitus, Duodenal Mucosal Resurfacing (DMR)

Eligibility

Locations

Lead Scientist at University of California Health

  • Adarsh Thaker (ucla)
    HS Assistant Clinical Professor, Medicine. Authored (or co-authored) 31 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Fractyl Health Inc.
ID
NCT04419779
Study Type
Interventional
Participants
Expecting 320 study participants
Last Updated