Revita T2Di Study
Diabetes Mellitus - Type 2 | Diseases of the Digestive System - Small Intestines, Large Intestines & Rectum
What is the purpose of this trial?
The purpose of this research study is to learn more about the use of the Fractyl Revita System for the treatment of Type 2 diabetes for patients who are on insulin therapy. Researchers are testing a new method, Duodenal mucosal resurfacing (DMR), which is a novel, minimally invasive, upper endoscopic procedure involving heating of the duodenal mucosa as a form of treatment for patients with type 2 Diabetes. You will be randomized to either Sham or DMR Procedure, with the opportunity to cross-over to the DMR procedure at the completion of the study. The study will last 2 years, with a total of 16 visits compensating at $100 per visit.
- Ages21 years - 70 years
- Trial withFractyl Laboratories, Inc.
- Start Date09/15/2021
- End Date05/31/2023
- Last Updated09/23/2021
- Study HIC#2000029448