Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorJSR Medical Co., Ltd.
About 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)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult males or females, 19-80 years of age, with signed informed consent
Subject whose anastomosis is expected to be located above 4cm from the anus, and at or below 15cm from the anus. (4cm < inclusion target ≤ 15cm from the anus).
Disqualifiers
Women who are pregnant or breastfeeding
Those who receive emergency surgery
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)
Trial design
Design model
Parallel
Treatments tested in this trial
COLO BT™
DeviceA 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)
Stoma Creation
Other interventionProtective ileostomy
Treatment groups
256 Participants
are divided into 2 treatment groupsGroup A: COLO BT™Experimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
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
Time frame
24 WeeksSponsors and contacts
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Source ClinicalTrials.gov