Efficacy and Safety of the CG-100 Intraluminal Bypass Device

October 21, 2025 updated by: Colospan Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 days after surgery only for patients who need it (i.e. have a defect in the anastomosis); thereby allowing patients with an intact anastomosis a quicker and safer return to normal activity.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Beersheba, Israel, 85025
      • Haifa, Israel, 8250490
      • Petah Tikva, Israel, 49100
        • Withdrawn
        • Rabin Medical Center
  • Italy
  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine
        • Contact:
        • Principal Investigator:
          • Joseph Carmichael, MD
      • San Diego, California, United States, 92123
        • Recruiting
        • Kaiser Permanente San Diego Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel Klaristenfeld, MD
        • Sub-Investigator:
          • Marco Tomassi, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Colorado University Anschutz Medical Campus
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jon Vogel, MD
        • Sub-Investigator:
          • Elisa Birnbaum, MD
        • Sub-Investigator:
          • Brandon Chapman, MD
        • Sub-Investigator:
          • Martin McCarter, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Active, not recruiting
        • University of Louisville
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Active, not recruiting
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Active, not recruiting
        • East Bank Hospital - M Health Fairview University of Minnesota Medical Center
    • New York
      • New York, New York, United States, 10021
        • Active, not recruiting
        • New York-Presbyterian / Weill Cornell Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Active, not recruiting
        • Jefferson University Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Active, not recruiting
        • Lifespan & Brown Surgical Associates
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Active, not recruiting
        • University of Utah Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CG-100
Patients receive CG-100 during rectal cancer surgery
Device: 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)
Active Comparator: SOC
Patients receive a protective stoma during rectal cancer surgery
Procedure: Stoma
Primary protective ileostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Stoma creation rate
Time Frame: 39 Weeks
39 Weeks
Incidence of complications
Time Frame: 39 Weeks
39 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colospan Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 1, 2019

First Submitted That Met QC Criteria

December 1, 2019

First Posted (Actual)

December 4, 2019

Study Record Updates

Last Update Posted (Estimated)

October 23, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLD-075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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