Use of the CG-100 intraluminal bypass device to reduce stoma formation after rectal cancer surgery.

Efficacy and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized Trial

This trial will test whether placing a temporary CG-100 bypass device at the time of mesorectal excision can reduce the need for a protective stoma in adults with rectal cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 22 Years to 70 Years
• Sex: All
• Sponsor: Colospan Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 14 sites (Orange, California and 13 other locations)
• Trial ID: NCT04184973 on ClinicalTrials.gov

What this trial studies

Adults with rectal cancer who are scheduled for elective mesorectal excision and would routinely receive a protective stoma are randomized to receive either the removable CG-100 intraluminal bypass device or standard stoma creation. The CG-100 is designed to divert the fecal stream for the first 10 days after surgery and allow stoma creation only if an anastomotic defect is detected. Key outcomes include the rate of stoma creation, device safety, and anastomotic leak–related complications with clinical follow-up. Eligible participants are aged 22–70 (with limited comorbidity allowances) and must be able to attend follow-up at participating US centers.

Who should consider this trial

Good fit: Ideal candidates are adults with rectal cancer scheduled for elective mesorectal excision with an anastomosis within 10 cm of the anal verge who would otherwise receive a protective stoma.

Not a fit: Patients who require a permanent stoma, have contraindications to an intraluminal bypass device, fall outside the age/comorbidity criteria, or cannot access a study center are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the device could let many patients avoid a protective stoma and reduce stoma-related complications and recovery time.

How similar studies have performed: Related approaches such as transanal tubes or temporary diversion have been studied with mixed results, and CG-100 is a newer intraluminal bypass device with limited prior clinical data.

Eligibility criteria

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 receive a protective stoma under routine clinical practice during their primary planned operation.
6. Patient is scheduled to undergo mechanical bowel preparation
7. 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).

Exclusion Criteria:

1. Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
2. 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).
3. Patients with ASA classification \> 3
4. Albumin \< 30 g/liter
5. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
6. Patients has a diagnosis of coagulopathy, thrombocytopenia, immune suppression
7. BMI ≥ 40
8. Patient is going through another surgical procedure (other than ileostomy, adhesiolysis) during the surgery.
9. The patient is currently participating in another investigational drug or device study unless pre-approved by the sponsor.
10. Patient has been taking regular systemic/ steroid medication in the last 6 months.
11. Patients is taking antimetabolites or antiplatelet agents.
12. Patient has preexisting sphincter problems
13. Patient has evidence of extensive local disease in the pelvis or has undergone a prior pelvic anastomosis.
14. Patients with massive diverticulosis at the sigmoid/descending colon (viewed on preoperative CT)
15. Any condition or abnormality which in the opinion of the investigator may jeopardize the patient's safe participation or the quality of the data
16. Pregnant or nursing female patients. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test.

Where this trial is running

Orange, California and 13 other locations

• University of California Irvine — Orange, California, United States (Recruiting)
• Kaiser Permanente San Diego medical Center — San Diego, California, United States (Recruiting)
• Colorado University Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
• University of Louisville — Louisville, Kentucky, United States (Active_not_recruiting)
• Henry Ford Health System — Detroit, Michigan, United States (Active_not_recruiting)
• East Bank Hospital - M Health Fairview University of Minnesota Medical Center — Minneapolis, Minnesota, United States (Active_not_recruiting)
• New York-Presbyterian / Weill Cornell Medical Center — New York, New York, United States (Active_not_recruiting)
• Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Active_not_recruiting)
• Lifespan & Brown Surgical Associates — Providence, Rhode Island, United States (Active_not_recruiting)
• University of Utah Health — Salt Lake City, Utah, United States (Active_not_recruiting)
• Soroka University Medical Center — Beersheba, Israel (Recruiting)
• Carmel Medical Center — Haifa, Israel (Recruiting)
• Rabin Medical Center — Petah Tikva, Israel (Withdrawn)
• Humanitas Research Hospital — Milan, Lombardy, Italy (Recruiting)

Study contacts

• Study coordinator: Jonathan Elsner, PhD, MBA

Conditions Rectal Cancer; Rectal Tumor; Rectal/Anal; anastomosis; leak; mesorectal; ileostomy; colostomy