Safety and Effectiveness Evaluations of the COLO-BT™ (Colorectal Balloon Tube) as an Alternative Treatment to the Temporary Ileostomy Following Proctectomy
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)
‣ 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
⁃ \- 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.