Status: Recruiting
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
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)
Participants needed: 256
Trial details
Age: 19-80Biological sex: AllType: InterventionalSponsor: JSR Medical Co., Ltd.Updated: Jun 13, 2025Locations: 3
Eligibility criteria
Adult males or females, 19-80 years of age, with signed informed consent [+1]
Women who are pregnant or breastfeeding [+27]