Improving Surgery Outcomes for Colorectal Cancer Patients with a New Device

Recruiting · Rectal Cancer and related conditions · 9 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This trial is looking at a device called CG-100 to help patients avoid having a stoma, which is a surgical opening made to help waste leave the body. It focuses on patients needing surgery for colorectal cancer. The goal is to see if this device can safely postpone the need for a stoma until it’s truly necessary, thus reducing complications for patients who don’t need one right away.

This is an investigational study with ID number NCT04184973. It is not looking at any drugs, but it is studying a device that is regulated by the FDA. The trial aims to include about 250 participants.

Who can join

Adults aged 22 to 70 years can participate. This includes both men and women with colorectal cancer who are scheduled for specific types of surgery. Patients should not have certain health issues or infections that could complicate their participation. The trial team will confirm who is eligible to join.

Conditions

Rectal Cancer, Rectal Tumor, Rectal/Anal

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be randomly assigned to one of two groups. One group will receive the CG-100 device during their surgery, and the other group will receive a protective stoma. Everyone will be monitored for any complications and the creation rate of stomas for up to 39 weeks after surgery.