109
Participants
Start Date
March 1, 2017
Primary Completion Date
December 20, 2019
Study Completion Date
December 20, 2019
DMR Procedure
The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
Sham Procedure
The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
Hopital Erasme, Brussels
Humanitas Research Hospital & Humanitas University Via Manzoni 56, Rozzano, Milan
UZ Leuven, Leuven
ABC Hospital, São Paulo
Hospital das Clinicas da Faculdade de medicina da Universidade de São Paulo, São Paulo
Policlinico Gemelli (Sacro Cuore), Rome
King's College, Denmark Hill, London
Amsterdam University Medical Center, Amsterdam
Glasgow Royal Infirmary, Glasgow
University College London Hospitals, London
Queens Medical Centre campus, Nottingham University Hospitals NHS Trust, Derby Road, Nottingham
Lead Sponsor
Fractyl Health Inc.
INDUSTRY