Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus
• Interventions: Device: DMR Procedure (Fractyl)

• Registration Number: NCT02413567
• Lead Sponsor: Fractyl Health Inc.

Brief Summary

The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-23
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-10
• Primary Completion: 2017-06-12
• Study Completion: 2019-09-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DMR Procedure	DMR Procedure (Fractyl)	Subjects receive the endoscopic DMR procedure in this arm

Primary Outcome Measures

Name	Time	Method
mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure	24 weeks post-procedure
Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)	24 weeks post-procedure

Trial Locations

Locations (7)

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

UZ Leuven; 🇧🇪 Leuven, Belgium

Università Cattolica del Sacro Cuore, Policlinico A. Gemelli; 🇮🇹 Rome, Lazio, Italy

University College London Hospitals; 🇬🇧 London, United Kingdom

Centro Clinico de Obesidad; 🇨🇱 Santiago, Chile

Hopital Erasme; 🇧🇪 Brussels, Belgium