Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus

• 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

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)

Hopital Erasme; 🇧🇪 Brussels, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Centro Clinico de Obesidad; 🇨🇱 Santiago, Chile

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

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

University College London Hospitals; 🇬🇧 London, United Kingdom

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