Efficacy and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized Trial
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.
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 day…
Eligibility
- Age range
- 22–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. The patient is willing to comply with protocol-specified follow-up evaluations 2. Patient 22-65 years of age at screening, or patient 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed. 3. Patient is diagnosed with colorectal cancer 4. Patient is scheduled for elective either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis, maximally 10 cm from the anal verge 5. Patients who are scheduled to r…
Interventions
- DeviceCG-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)
- ProcedureStoma
Primary protective ileostomy
Locations (14)
- University of California IrvineOrange, California
- Kaiser Permanente San Diego medical CenterSan Diego, California
- Colorado University Anschutz Medical CampusAurora, Colorado
- University of LouisvilleLouisville, Kentucky
- Henry Ford Health SystemDetroit, Michigan
- East Bank Hospital - M Health Fairview University of Minnesota Medical CenterMinneapolis, Minnesota