Fractyl Health, Inc.
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2010-01-01
- Employees
- 51
- Market Cap
- -
- Website
- http://www.fractyl.com
Evaluation of the Safety and Efficacy of Revita® DMR on Body Weight Maintenance in Subjects with Obesity Who Have Achieved At Least 15% Weight Loss on Tirzepatide
- Conditions
- Weight Change TrajectoryWeight Change, BodyObesity
- Interventions
- Device: Revita Duodenal Mucosal Resurfacing (DMR)Device: Sham
- First Posted Date
- 2024-07-03
- Last Posted Date
- 2025-03-14
- Lead Sponsor
- Fractyl Health Inc.
- Target Recruit Count
- 315
- Registration Number
- NCT06484114
- Locations
- 🇺🇸
Nature Coast Clinical Research, Inverness, Florida, United States
🇺🇸Jacksonville Center for Clinical Research, Jacksonville, Florida, United States
🇺🇸K2 Medical Research South Orlando, Orlando, Florida, United States
A Prospective Study to Evaluate Revita DMR Post Market Pilot Clinical Follow-Up Registry in Patient with Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Device: Duodenal Mucosal Resurfacing (DMR)
- First Posted Date
- 2024-02-13
- Last Posted Date
- 2025-03-14
- Lead Sponsor
- Fractyl Health Inc.
- Target Recruit Count
- 100
- Registration Number
- NCT06256497
- Locations
- 🇩🇪
Westdeutsches Diabetes und Gesundheitszentrum, Duesseldorf, Germany
Evaluation of the Efficacy and Safety of DMR Using the Revita® in Subjects With Inadequately Controlled Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Device: Duodenal Mucosal Resurfacing (DMR)Device: Duodenal Mucosal Resurfacing (Sham)
- First Posted Date
- 2020-06-05
- Last Posted Date
- 2025-02-05
- Lead Sponsor
- Fractyl Health Inc.
- Target Recruit Count
- 320
- Registration Number
- NCT04419779
- Locations
- 🇺🇸
Helios CR, Inc, Phoenix, Arizona, United States
🇺🇸HonorHealth Research Institute, Scottsdale, Arizona, United States
🇺🇸Mayo Clinic Arizona, Scottsdale, Arizona, United States
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revitaâ„¢ System in Treatment of Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Device: Duodenal Mucosal Resurfacing Sham (Sham)Device: Duodenal Mucosal Resurfacing (DMR)
- First Posted Date
- 2018-08-31
- Last Posted Date
- 2024-02-14
- Lead Sponsor
- Fractyl Health Inc.
- Target Recruit Count
- 9
- Registration Number
- NCT03653091
- Locations
- 🇺🇸
University of Pennsylvania - Penn Metabolic Medicine, Philadelphia, Pennsylvania, United States
🇺🇸Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸UTHealth, Houston, Texas, United States
Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)
- Conditions
- Diabetes Mellitus, Type 2Noninsulin-Dependent Diabetes Mellitus
- Interventions
- Procedure: Sham ProcedureProcedure: DMR Procedure
- First Posted Date
- 2016-08-25
- Last Posted Date
- 2024-02-14
- Lead Sponsor
- Fractyl Health Inc.
- Target Recruit Count
- 109
- Registration Number
- NCT02879383
- Locations
- 🇬🇧
University College London Hospitals, London, United Kingdom
🇮🇹Policlinico Gemelli (Sacro Cuore), Rome, Lazio, Italy
🇧🇪Hopital Erasme, Brussels, Belgium
Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2Diabetes Mellitus
- Interventions
- Device: DMR Procedure (Fractyl)
- First Posted Date
- 2015-04-10
- Last Posted Date
- 2024-02-14
- Lead Sponsor
- Fractyl Health Inc.
- Target Recruit Count
- 60
- Registration Number
- NCT02413567
- Locations
- 🇬🇧
King's College Hospital NHS Foundation Trust, London, United Kingdom
🇳🇱Academic Medical Center, Amsterdam, Netherlands
🇧🇪UZ Leuven, Leuven, Belgium
Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes
- Conditions
- Type II Diabetes
- Interventions
- Device: Fractyl Duodenal Remodeling System
- First Posted Date
- 2013-08-22
- Last Posted Date
- 2024-02-14
- Lead Sponsor
- Fractyl Health Inc.
- Target Recruit Count
- 57
- Registration Number
- NCT01927562
- Locations
- 🇨🇱
INDISA, Santiago, Chile