Trial to Evaluate Efficacy+Safety of Revita DMR Treatment Paradigm 1 and Retreatment in Type 2 Diabetes Patients

NARecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 9, 2024

Primary Completion Date

April 1, 2026

Study Completion Date

December 1, 2026

Conditions
Diabetes Mellitus, Type 2
Interventions
DEVICE

Revita® DMR Treatment

"The Revita® System is an endoscopic treatment consisting of a single catheter and console designed to lift the duodenal mucosa with saline followed by controlled circumferential hydrothermal ablation of the mucosa. For this study Revita® DMR procedure will be conducted as follows:~DMR Treatment Paradigm 1- After initial 2 Lift and Ablate step, remaining Lift: Ablate steps will be conducted in 1:1 manner."

OTHER

Sham procedure

The sham control for the Revita DMR procedure.

Trial Locations (1)

Unknown

RECRUITING

Amsterdam UMC, locatie VUmc, Amsterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Fractyl Health Inc.

INDUSTRY

lead

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER