Actively Recruiting
Safety and Effectiveness Evaluations of the COLO-BT™ (Colorectal Balloon Tube) as an Alternative Treatment to the Temporary Ileostomy Following Proctectomy
Led by JSR Medical Co., Ltd. · Updated on 2025-06-13
256
Participants Needed
3
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the COLO-BT™ device as a temporary, single-use tool designed to reduce contact of fecal content with the surgical connection site after colorectal surgery. The study aims to compare this device against the standard protective ileostomy to see if it can safely postpone or avoid the need for a stoma, which often causes complications in patients. Participants are randomly assigned to receive either the COLO-BT™ device during surgery or the standard care involving protective stoma creation. The device is intended for patients whose surgical connection (anastomosis) is healing properly, allowing others to avoid stoma-related complications. The study focuses on colorectal surgeries performed either by open or laparoscopic methods. During the study, participants will be monitored for up to 24 weeks to assess the success of avoiding an ostomy. Follow-up evaluations include clinical assessments and compliance with study procedures. Researchers will closely observe safety outcomes and the healing progress of the anastomosis to determine the effectiveness of the COLO-BT™ device compared to standard care.
CONDITIONS
Brief Title
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males or females, 19-80 years of age, with signed informed consent
- Anastomosis expected to be located above 4 cm and at or below 15 cm from the anus
- Willing and able to participate in the study, provide informed consent, and comply with procedures
- Willingness to undergo blood transfusion if required
- High-risk patients include those who are male, have a body mass index of 30 or higher, are current smokers, have diabetes medication, have clinical stage III or higher tumors, or received chemo/radiation before surgery (not required but considered)
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Patients receiving emergency surgery
- Patients needing intensive medical care after surgery due to serious conditions such as abnormal bone marrow function, severe liver damage, kidney failure requiring dialysis, recent cardiac or cerebrovascular stent procedures, recent pulmonary tuberculosis, high-dose steroid use, ASA score above 3, immune suppression, severe diverticulosis, or colonic wall abnormalities increasing device risk
- Patients with psychiatric or neurological disorders affecting communication or mobility
- Patients with intestinal perforation, pelvic abscess, or severe pelvic inflammation
- Patients with history of major surgeries likely causing serious adhesions
- Patients with anastomosis very close to the anus or expected significant future bowel dysfunction
- Patients who had preoperative radiotherapy
- Patients with inflammatory bowel or autoimmune diseases
- Patients who do not consent in writing
- Patients with significant blood loss or transfusion near randomization
- Patients with signs of ischemia or certain bowel diagnoses within 6 weeks before randomization
- Known allergies to procedure components
- Other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive either the COLO BT™ device or a protective stoma during colorectal surgery to protect the anastomosis.
Visits scheduled according to post-surgical care and monitoring needs
Trial Site Locations
Total: 3 locations
1
Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
2
PennState Health - Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
3
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
K
Kim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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