Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy

Recruiting N/A Interventional Study
Colorectal Surgery Colorectal Cancer Rectal/Anal Ileostomy - Stoma Anastomotic Leakage
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
19 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
256 (estimated)
Sponsor
JSR Medical Co., Ltd. · Industry
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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)

Trial Locations
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Eligibility Criteria
Inclusion Criteria: The patient must meet all study Inclusion Criteria as outlined below: * 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 \< inclusi…
Contacts

Kim

+82-10-9345-1058

jakehykim@jsrmed.co.kr

CONTACT