Efficacy and Safety of the CG-100 Intraluminal Bypass Device
1 other identifier
interventional
250
3 countries
14
Brief Summary
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2019
CompletedFirst Posted
Study publicly available on registry
December 4, 2019
CompletedStudy Start
First participant enrolled
June 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
October 23, 2025
October 1, 2025
6.5 years
December 1, 2019
October 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Stoma creation rate
39 Weeks
Incidence of complications
39 Weeks
Study Arms (2)
CG-100
EXPERIMENTALPatients receive CG-100 during rectal cancer surgery
SOC
ACTIVE COMPARATORPatients receive a protective stoma during rectal cancer surgery
Interventions
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)
Eligibility Criteria
You may qualify if:
- The patient is willing to comply with protocol-specified follow-up evaluations
- 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.
- Patient is diagnosed with colorectal cancer
- 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
- Patients who are scheduled to receive a protective stoma under routine clinical practice during their primary planned operation.
- Patient is scheduled to undergo mechanical bowel preparation
- The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).
You may not qualify if:
- Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
- Major surgical or interventional procedures within 45 days prior to this study or planned surgical or interventional procedures within 6 months of entry into this study (not including, placement of port for chemotherapy or ureter stent insertion).
- Patients with ASA classification \> 3
- Albumin \< 30 g/liter
- Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
- Patients has a diagnosis of coagulopathy, thrombocytopenia, immune suppression
- BMI ≥ 40
- Patient is going through another surgical procedure (other than ileostomy, adhesiolysis) during the surgery.
- The patient is currently participating in another investigational drug or device study unless pre-approved by the sponsor.
- Patient has been taking regular systemic/ steroid medication in the last 6 months.
- Patients is taking antimetabolites or antiplatelet agents.
- Patient has preexisting sphincter problems
- Patient has evidence of extensive local disease in the pelvis or has undergone a prior pelvic anastomosis.
- Patients with massive diverticulosis at the sigmoid/descending colon (viewed on preoperative CT)
- Any condition or abnormality which in the opinion of the investigator may jeopardize the patient's safe participation or the quality of the data
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Colospan Ltd.lead
Study Sites (14)
University of California Irvine
Orange, 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
University of Louisville
Louisville, Kentucky, 40202, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
East Bank Hospital - M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
New York-Presbyterian / Weill Cornell Medical Center
New York, New York, 10021, United States
Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Lifespan & Brown Surgical Associates
Providence, Rhode Island, 02906, United States
University of Utah Health
Salt Lake City, Utah, 84132, United States
Soroka University Medical Center
Beersheba, 85025, Israel
Carmel Medical Center
Haifa, 8250490, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Humanitas Research Hospital
Milan, Lombardy, 20089, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2019
First Posted
December 4, 2019
Study Start
June 23, 2020
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
October 23, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share