Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
COLO-BT
1 other identifier
interventional
256
1 country
3
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2023
CompletedFirst Posted
Study publicly available on registry
April 24, 2023
CompletedStudy Start
First participant enrolled
December 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 15, 2027
June 13, 2025
June 1, 2025
3 years
April 12, 2023
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Study Success Case(Avoidance of ostomy)
Study Success Case" is defined as a case which has met both the "Clinical Success" and "Technical Success" requirements throughout the 24 weeks (6 Months) monitoring period, following the initial surgical treatment with COLO-BT™ or temporary ileostomy
24 Weeks
Study Arms (2)
COLO BT™
EXPERIMENTALPatients receive COLO BT™ during colorectal surgery.
Standard of Care
ACTIVE COMPARATORPatients receive the standard of care, a protective stoma, during colorectal surgery.
Interventions
A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma after surgery for only patients who need it (do not have a healed anastomosis)
Eligibility Criteria
You may qualify if:
- Adult males or females, 19-80 years of age, with signed informed consent
- \- Male
- \- Those with a body mass index of 30 or higher
- \- Current smoker
- \- Those who are on medication for diabetes
- \- Those with clinical stage III or higher malignant tumors
- \- Those who received chemo/radiation therapy before surgery
- ④ Those who are willing and able to participate in this clinical study, provide Informed Consent, and are willing to comply with the study procedures and follow up evaluations
- ⑤ Those who have willingness to undertake blood transfusion if required.
You may not qualify if:
- Women who are pregnant or breastfeeding
- Those who receive emergency surgery
- A person who is expected to need intensive medical care after the surgery due to a serious medical condition, with one or more of the following seven factors being true:
- Patients with abnormal bone marrow function (those with hemoglobin less than 7g/dl, leukocyte count less than 4000/mm3, or platelet count less than 100,000/mm3 even after preoperative corrections)
- Patients with severe liver damage or cirrhosis (those whose AST/ALT levels are more than three times the normal range or those diagnosed with cirrhosis)
- Those with abnormal renal function (those who are on hemodialysis or who have a blood creatinine level of 2.0mg/dl or more before the surgery)
- Those who have undergone cardiac or cerebrovascular stent procedure within the last 6 months
- Those who have been diagnosed with pulmonary tuberculosis within the last 6 months or are undergoing drug treatment for pulmonary tuberculosis
- Those who continuously administer steroids of 20mg/day or more within 30 days before the surgery
- Patients with ASA (American Society of Anesthesiologists) score of 3 are evaluated by the investigator who determines whether or not patients with ASA score of 3 should be enrolled from the patient safety standpoint. Patients with ASA score higher than 3 are excluded from this study.
- Patients who are required to undergo re-intervention to treat the anastomosis following intraoperative positive air leak test (However, patients who underwent complete reconstruction of the anastomosis in the presence of a positive air test, which therefore has made their risk of leak similar to those patients with a negative air leak test.)
- Patients who are immune suppressed
- Patients with severe diverticulosis
- Patients with other colonic wall abnormalities in the likely area of the Outer Balloon and BT BAND application who may be at increased risk for device perforation or migration.
- A person who has difficulty in mobility or is unable to communicate in general due to a psychiatric/neurologic disorder falling under one or more of the following:
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo
Buffalo, New York, 14203, United States
PennState Health - Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A Falvo, MD
Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2023
First Posted
April 24, 2023
Study Start
December 4, 2023
Primary Completion (Estimated)
December 15, 2026
Study Completion (Estimated)
March 15, 2027
Last Updated
June 13, 2025
Record last verified: 2025-06