320
Participants
Start Date
March 8, 2021
Primary Completion Date
June 30, 2025
Study Completion Date
January 31, 2026
Duodenal Mucosal Resurfacing (DMR)
The Fractyl DMR Procedure utilizes the Revita® Catheter to perform hydrothermal ablation of the duodenum. The Catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DMR treatment are followed for 48 weeks post treatment.
Duodenal Mucosal Resurfacing (Sham)
The Sham procedure consists of placing the Revita® Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient. Subjects who receive the Sham procedure are followed for 48 weeks post treatment and are offered cross over to undergo the DMR procedure at 48 weeks and are followed for further 48 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.
NYU Langone Gastroenterology Associates, New York
Synexus Clinical Research, New York, New York
Icahn School of Medicine at Mount Sinai, New York
Weill Cornell Medicine, New York
Preferred PCP - Pittsburgh, Pittsburgh
Preferred Primary Care Physicians, Pittsburgh
University of Pennsylvania, Philadelphia
West Virginia University, Morgantown
M3 Wake Research, Raleigh
Duke University Medical Center, Durham
AcellaCare Salisbury, Salisbury
AcellaCare Wilmington, Wilmington
AcellaCare Piedmont, Statesville
Northeast Research Institute, Llc, Fleming Island
Jacksonville Center for Clinical Research, Jacksonville
Advent Health Orlando, Orlando
Synexus Research, Orlando
University of Miami, Miami
West Orange Endocrinology, Ocoee
University of Louisville, Louisville
Cleveland Clinic, Cleveland
Investigators Research Group, Brownsburg
AHN - Avon, Avon
AHN- Franklin, Franklin
AHN - Greenfield, Greenfield
Indiana University School of Medicine, Indianapolis
AHN - Muncie, Muncie
University of Michigan, Ann Arbor
Northwestern Unviersity, Evanston
Washington University School of Medicine, St Louis
IMA Clinical Research St. Louis, St Louis
Jefferson City Medical Group, Jefferson City
Tulane University, New Orleans
Baylor St. Luke's Medical Center, Houston
Endocrine Associates of West Village, Long Island City
Biopharma Informatic, Llc, Houston
Simcare Medical Research, Llc., Sugar Land
Helios CR, Inc, Phoenix
HonorHealth Research Institute, Scottsdale
Mayo Clinic Arizona, Scottsdale
Angel City Research , Inc., Los Angeles
UCLA Health, Los Angeles
Care Access Santa Clarita, Newhall
Hoag Hospital, Newport Beach
Stanford University Medical Center, Redwood City
Mills Peninsula Health Center, San Mateo
Seattle Cancer Care Alliance, Seattle
Brigham and Women's Hospital, Boston
Alcanza Clinical Research, LLC, Methuen
Dartmouth-Hitchcock Medical Center, Lebanon
Care Access Warwick, Warwick
Cliniques Universitaires de Bruxelles Hopital Erasme, Brussels
University College Dublin, Dublin
Italy Gemelli, Roma
Universiteit Van Amsterdam Academisch Medisch Centrum, Amsterdam
King's College Hospital, London
University Hospital Zurich, Zurich
Cleveland Clinic London, London
Lead Sponsor
Fractyl Health Inc.
INDUSTRY