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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kaiser Permanente San Diego medical Center
  San Diego, California, United States Recruiting
• Colorado University Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• Henry Ford Health System
  Detroit, Michigan, United States Recruiting
• Asklepios
  Hamburg, Germany Recruiting
• Soroka University Medical Center
  Beersheba, Israel Recruiting
• Humanitas Research Hospital
  Milan, Lombardy, Italy Recruiting

Study contacts

• Study coordinator: Boaz Assaf
• Email: boaz@colospan.com
• Phone: +972-9-7672518

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.