CG-100 Intraluminal Bypass Device for Rectal Cancer

This study is testing a device called CG-100, a temporary bypass device, to see if it can reduce the need for a protective stoma (a surgically created opening to divert waste) in people having surgery for rectal cancer. Currently, many patients receive a stoma even if they don't end up needing it. The CG-100 device aims to delay stoma creation until 10 days after surgery, only for those who truly need it due to complications. Researchers will compare the rate of stoma creation and complications in people who receive the CG-100 device versus those who receive a standard protective stoma. You may be able to join if you are between 22 and 70 years old, diagnosed with colorectal cancer, and willing to follow the study's plan. The study's current status is unclear, and it plans to enroll 250 participants.

Study design
This is a randomized study, meaning participants will be assigned by chance to receive either the CG-100 device or a standard stoma. It aims to enroll 250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in stoma creation rate and incidence of complications for 39 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04184973

Efficacy and Safety of the CG-100 Intraluminal Bypass Device

Recruiting
NAAges 22–70InterventionalPrevention
Colospan Ltd.
~250 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:CG-100 intraluminal bypass deviceStoma

At a glance

Recruiting sites
7 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Stoma creation rate
Measured over 39 Weeks
+1 more outcome measured
Rectal Cancer
Rectal Tumor
Rectal/Anal
10 sites across 9 states
California2
Colorado1
Michigan1
Rhode Island1
Utah1
Germany1
Israel1
Lombardy1

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  • Change in Stoma creation rate39 Weeks
  • Incidence of complications39 Weeks