315
Participants
Start Date
September 1, 2024
Primary Completion Date
September 30, 2026
Study Completion Date
September 30, 2027
Revita Duodenal Mucosal Resurfacing (DMR)
DMR is designed to ablate and re-epithelialize the duodenal mucosal surface, thus allowing nutrients to be exposed to a newly regrown and potentially normalized local mucosa. This implies that the duodenal mucosa surface is abnormal in participants associated with metabolic disorders. The Revita DMR procedure is performed endoscopically with supporting fluoroscopy.
Sham
An endoscopic review with non active catheter introduction
NYU-Langone, New York
NYC Research, Inc. (Endocrine Associates of West Village), Long Island City
Preferred Primary Care Physician Pittsburgh, Pittsburgh
Preferred Primary Care Physician, Pittsburgh
Preferred Primary Care Physician, Uniontown
West Virginia University, Morgantown
Nature Coast Clinical Research, Inverness
Synexus Clinical Research Institute - The Villages (AES), The Villages
Jacksonville Center for Clinical Research, Jacksonville
Encore Borland-Groover Clinical Research, Jacksonville
Advent Health, Orlando
K2 Medical Research South Orlando, Orlando
Orlando Health Weight Loss and Bariatric Surgery Institute, Orlando
Zenith Clinical Research, Hollywood
International Research Associates, Miami
Cleveland Clinic, Weston, Weston
Metabolic Research Institute, West Palm Beach
Investigators Research Group, LLC, Brownsburg
American Health Network - Franklin, Franklin
American Health Network - Greenfield, Greenfield
Indiana University, Indianapolis
American Health Network - Muncie, Muncie
University of Michigan, Ann Arbor
Baylor St. Luke's Medical Center, Houston
Juno Research, LLC, Houston
Simcare Medical Research LLC, Sugar Land
Helios Clinical Research, Phoenix
Honor Health, Scottsdale
UCLA Santa Monica Medical Center, Santa Monica
Hoag Hospital, Newport Beach
University of Washington, Seattle, Seattle
Dartmouth-Hitchcock Medical Center, Lebanon
Lead Sponsor
Fractyl Health Inc.
INDUSTRY