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Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)

NCT02879383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2024-02-14

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 2
  • Noninsulin-Dependent Diabetes Mellitus

Interventions

PROCEDURE

DMR Procedure

The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System

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.

Sponsors & Collaborators

  • Fractyl Health Inc.

    lead INDUSTRY

Principal Investigators

  • Geltrude Mingrone, MD, PhD · Gemelli University Hospital, Rome

  • Jacques Bergman, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
28 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2019-12-20
Completion
2019-12-20

Countries

  • Belgium
  • Brazil
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02879383 on ClinicalTrials.gov