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.
Efficacy and Safety of the CG-100 Intraluminal Bypass Device
At a glance
Conditions
Where it's being run
10 sites across 9 statesWho to contact
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What this trial measures
- Change in Stoma creation rate39 Weeks
- Incidence of complications39 Weeks