Safety and Effectiveness Evaluations of the COLO-BT™ (Colorectal Balloon Tube) as an Alternative Treatment to the Temporary Ileostomy Following Proctectomy
JSR Medical Co., Ltd.
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)
Description
A primary diverting stoma is widely used by surgeons in order to bypass low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which mean that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit. COLO BT™ is a local, temporary bypass device that provides protection of the anastomosis and safely postpones stoma. COLO BT™ is designed to avoid stoma creation in all patients except those patients whose anastomoses have not healed after surgery,…
Eligibility
- Age range
- 19–80 years
- Sex
- All
- Healthy volunteers
- Yes
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 \< inclusion target ≤ 15cm from the anus). ③ Patient must meet all other inclusion criteria to be eligible. While not required, if one or more of the following six risk factors for postoperative anastomotic leakage\[6,7,8\] is true, the patient will be considered a high-risk subject: \- Male \-…
Interventions
- DeviceCOLO BT™
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)
- OtherStoma Creation
Protective ileostomy
Locations (3)
- Jacobs School of Medicine & Biomedical Sciences, State University of New York at BuffaloBuffalo, New York
- PennState Health - Milton S. Hershey Medical CenterHershey, Pennsylvania
- Baylor College of MedicineHouston, Texas