Actively Recruiting
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
Led by JSR Medical Co., Ltd. · Updated on 2025-06-13
256
Participants Needed
3
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official 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 aged 19 to 80 years 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 clinical study and comply with procedures and follow-up
- Willing to undertake blood transfusion if required
- Patients with one or more high-risk factors for postoperative anastomotic leakage (male, BMI 30 or higher, current smoker, diabetes medication, clinical stage III or higher malignant tumors, prior chemo/radiation therapy) are included but not required
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients undergoing emergency surgery
- Patients expected to need intensive medical care after surgery due to serious conditions such as severe bone marrow dysfunction, severe liver damage or cirrhosis, abnormal renal function, recent cardiac or cerebrovascular stent, recent pulmonary tuberculosis, high steroid use, ASA score higher than 3, immune suppression, severe diverticulosis, or colonic wall abnormalities increasing risk of device complications
- Patients with psychiatric or neurological disorders impairing communication or mobility, including dementia, Alzheimer's, schizophrenia, depression, or intellectual disability
- Patients with intestinal perforation, pelvic abscess, or severe pelvic inflammation
- History of major surgeries likely causing serious adhesions affecting this surgery
- Patients with anastomosis very close to the anus or anal canal after preoperative chemotherapy
- Patients who had pre-operative radiotherapy
- Patients with inflammatory bowel diseases or autoimmune diseases such as ulcerative colitis, Crohn's disease, intestinal tuberculosis, or Bechet's disease
- Patients who do not provide written consent
- Recent significant blood loss or transfusion
- New signs of ischemia or intraabdominal infections related to carcinomatosis within 6 weeks before randomization
- Known allergy to any components required for the procedure
- Any other condition deemed unsuitable by the researcher for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here