Recruiting

CG-100

Sponsor:

Colospan Ltd.

Code:

NCT04184973

Conditions

Rectal Cancer

Rectal Tumor

Rectal/Anal

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Not accepted

Interventions

CG-100 intraluminal bypass device

Stoma

Study Details

Brief summary:

A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.

Conditions

Rectal Cancer

Rectal Tumor

Rectal/Anal

Study ID

NCT04184973

Start date

Jun 23, 2020

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: CG-100

Patients receive CG-100 during rectal cancer surgery

active comparator: SOC

Patients receive a protective stoma during rectal cancer surgery

Interventions

CG-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)

Stoma

Primary protective ileostomy

Primary outcome measure

  • Change in Stoma creation rate [ Time Frame: 39 Weeks ]
  • Incidence of complications [ Time Frame: 39 Weeks ]

Central Contacts and Locations

Central contacts

Locations

Kaiser Permanente San Diego medical Center

Recruiting

San Diego, California, United States, 92123

Contacts

Principal Investigator:

Daniel Klaristenfeld, MD

Colorado University Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Jon Vogel, MD

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Principal Investigator:

Craig Reickert, MD

More Information

Sponsor

Colospan Ltd.

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • anastomosis
  • leak
  • mesorectal
  • ileostomy
  • colostomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colospan Ltd. on 2026-07-06.