RevitaT2Di Pivotal Study (REVITALIZE 1)
Brief description of study
The Revitalize-1 Study will look at a potential procedure called duodenal mucosal resurfacing (DMR). The DMR procedure acts on the first layer (mucosa) of the duodenum (the part of the small intestine located immediately after the stomach). By removing an excess layer, the treatment may improve blood sugar control. This treatment may eliminate or reduce the need for insulin injections in the future for the treatment of Type 2 Diabetes.
Detailed description of study
Study participation will last for a total of 48-96 weeks. You will be compensated for participation in this study and will not have to pay for any study procedures. In addition to receiving either the Revita™ DMR procedure or control procedure, you will receive diabetes medication counseling and will undergo the following medical procedures: routine blood work, EKG, and endoscopy.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Type 2 Diabetes
-
Age: Between 21 Years - 70 Years
-
Gender: All
You may be eligible for this study if:
- You have Type 2 Diabetes
- You are using insulin
- Your A1c is between 7.5% and 10%
- Your BMI is between 24 and 40
Updated on
09 Mar 2024.
Study ID: 849853
Pre-Screener
