Efficacy and Safety of the CG-100 Intraluminal Bypass Device
Start Date
6/23/2020
Completion Date
12/31/2026
Summary
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
Detailed Description
A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Today a stoma is created for all high-risk patients even though the expected anastomotic leak rate is less than 20%. This means that 80% of patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit. CG-100, a removable, temporary intraluminal bypass device, developed by Colospan, is designed to address this need by safely postponing 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); thereby allowing patients with an intact anastomosis a quicker and safer return to normal activity.
Eligibility Criteria
Age Range: 22 years to 70 years
Interventions
CG-100 intraluminal bypass device
Stoma
Conditions
Locations
University of California Irvine
Irvine, California 92868
United States
Kaiser Permanente San Diego medical Center
San Diego, California 92123
United States
Colorado University Anschutz Medical Campus
Aurora, Colorado 80045
United States
Henry Ford Health System
Detroit, Michigan 48202
United States
Lifespan & Brown Surgical Associates
Providence, Rhode Island 02906
United States
University of Utah Health
Salt Lake City, Utah 84132
United States
Asklepios
Hamburg,
Germany
Soroka University Medical Center
Beersheba, 85025
Israel
Humanitas Research Hospital
Milan, Lombardy 20089
Italy
CHUV
Lausanne,
Switzerland