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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
109
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.
Hopital Erasme
Brussels, Belgium
UZ Leuven
Leuven, Belgium
ABC Hospital
São Paulo, Brazil
Change From Baseline at 24 Weeks in Hemoglobin A1c (HbA1c), DMR vs Sham.
The primary efficacy endpoint is the change from baseline at 24 weeks in HbA1c, DMR vs Sham
Time frame: Baseline and 24 Weeks post-procedure
Change From Baseline at 12 Weeks in MR-PDFF, DMR vs Sham
The absolute change from baseline at 12 weeks in MR-PDFF in patients with baseline MR-PDFF \> 5% , DMR vs Sham
Time frame: Baseline and 12 Weeks post-procedure
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Hospital das Clinicas da Faculdade de medicina da Universidade de São Paulo
São Paulo, Brazil
Policlinico Gemelli (Sacro Cuore)
Rome, Lazio, Italy
Humanitas Research Hospital & Humanitas University Via Manzoni 56, Rozzano
Milan, Italy
Amsterdam University Medical Center
Amsterdam, Netherlands
Glasgow Royal Infirmary
Glasgow, United Kingdom
University College London Hospitals
London, United Kingdom
King's College, Denmark Hill
London, United Kingdom
...and 1 more locations