18
Participants
Start Date
August 9, 2024
Primary Completion Date
April 1, 2026
Study Completion Date
December 1, 2026
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."
Sham procedure
The sham control for the Revita DMR procedure.
RECRUITING
Amsterdam UMC, locatie VUmc, Amsterdam
Collaborators (1)
Fractyl Health Inc.
INDUSTRY
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER