COLO BT™ Device for Colorectal Surgery Recovery
(COLO-BT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are taking steroids of 20mg/day or more, you may not be eligible to participate.
How is the COLO-BT™ treatment different from other treatments for colorectal surgery recovery?
The COLO-BT™ treatment is unique because it uses a balloon tube specifically designed for colorectal surgery recovery, which may help in managing post-surgical complications by providing targeted support and pressure to the affected area. This approach is different from standard treatments that might not use such a device to aid recovery.12345
What data supports the effectiveness of the COLO-BT™ treatment for colorectal surgery recovery?
Who Is on the Research Team?
Mark A Falvo, MD
Principal Investigator
Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo
Are You a Good Fit for This Trial?
Adults aged 19-80 needing colorectal surgery with anastomosis between 4-15cm from the anus. Must have one risk factor like obesity, smoking, diabetes, stage III+ cancer, or pre-surgery chemo/radiation. Excludes those with severe medical conditions, recent major surgeries affecting the area, emergency surgery needs, pregnant/breastfeeding women, and certain blood disorders.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive COLO BT™ or standard of care during colorectal surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- COLO-BT™
- Stoma Creation
COLO-BT™ is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
JSR Medical Co., Ltd.
Lead Sponsor