At a glance
ClinicalIndex Comparison Record- ✓Age 28–75 years
- ✓Type 2 diabetes diagnosis with evidence of preserved insulin secretion (fasting insulin >7 μU/mL)
- ✓HbA1c 7.5–10.0% (59–86 mmol/mol)
- ✓BMI 24–40 kg/m²
- ✕Type 1 diabetes or history of ketoacidosis
- ✕Current insulin or GLP-1 analogue use
- ✕Hypoglycemia unawareness or >1 severe hypoglycemic event in the past year requiring third-party assistance
- ✕Autoimmune disease (positive GAD, celiac disease, SLE, scleroderma, or other autoimmune connective tissue disorder)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)
In Brief
A clinical study evaluating DMR Procedure and Sham Procedure for Diabetes Mellitus, Type 2 and Noninsulin-Dependent Diabetes Mellitus. Completed, enrolled 109 participants across 11 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.