Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02879383|
Recruitment Status : Active, not recruiting
First Posted : August 25, 2016
Last Update Posted : July 30, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Noninsulin-Dependent Diabetes Mellitus||Procedure: DMR Procedure Procedure: Sham Procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of the Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: DMR Procedure
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
Procedure: DMR Procedure
The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
Sham Comparator: Sham Procedure
Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.
Procedure: Sham Procedure
The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
- Change from baseline at 24 weeks in hemoglobin A1c (HbA1c), DMR vs Sham. [ Time Frame: 24 Weeks post-procedure ]The primary efficacy endpoint is the change from baseline at 24 weeks in HbA1c, DMR vs Sham
- Change from baseline at 12 weeks in MR-PDFF, DMR vs Sham [ Time Frame: 12 Weeks post-procedure ]The absolute change from baseline at 12 weeks in MR-PDFF in patients with baseline MR-PDFF > 5% , DMR vs Sham
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879383
|Brussels, Belgium, 1070|
|Hospital das Clinicas da Faculdade de medicina da Universidade de São Paulo|
|Sao Paulo, Brazil|
|São Paulo, Brazil|
|Policlinico Gemelli (Sacro Cuore)|
|Rome, Lazio, Italy|
|Humanitas Research Hospital & Humanitas University Via Manzoni 56, Rozzano|
|Milano, Italy, 20089|
|Amsterdam University Medical Center|
|Amsterdam, Netherlands, 1105 AZ|
|Glasgow Royal Infirmary|
|Glasgow, United Kingdom, G4 0SF|
|University College London Hospitals|
|London, United Kingdom, NW1 2BU|
|King's College, Denmark Hill|
|London, United Kingdom|
|Queens Medical Centre campus, Nottingham University Hospitals NHS Trust, Derby Road|
|Nottingham, United Kingdom, NG7 2UH|