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Efficacy and Safety of the CG-100 Intraluminal Bypass Device
Sponsor: Colospan Ltd.
Summary
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
Official title: Efficacy and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized Trial
Key Details
Gender
All
Age Range
22 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2020-06-23
Completion Date
2026-12-31
Last Updated
2025-10-23
Healthy Volunteers
No
Conditions
Interventions
CG-100 intraluminal bypass device
a removable, temporary intraluminal bypass device, developed by Colospan, is designed to safely postpone the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis)
Stoma
Primary protective ileostomy
Locations (14)
University of California Irvine
Orange, California, United States
Kaiser Permanente San Diego medical Center
San Diego, California, United States
Colorado University Anschutz Medical Campus
Aurora, Colorado, United States
University of Louisville
Louisville, Kentucky, United States
Henry Ford Health System
Detroit, Michigan, United States
East Bank Hospital - M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
New York-Presbyterian / Weill Cornell Medical Center
New York, New York, United States
Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Lifespan & Brown Surgical Associates
Providence, Rhode Island, United States
University of Utah Health
Salt Lake City, Utah, United States
Soroka University Medical Center
Beersheba, Israel
Carmel Medical Center
Haifa, Israel
Rabin Medical Center
Petah Tikva, Israel
Humanitas Research Hospital
Milan, Lombardy, Italy