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)

Trial Details

NCT ID
NCT05826743
Phase
NA
Sponsor
JSR Medical Co., Ltd.
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • COLO BT™
  • Stoma Creation
Locations (sample)
  • Buffalo, New York, United States|42.88645,-78.87837
  • Hershey, Pennsylvania, United States|40.28592,-76.65025
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility 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 fr…
  • 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 postopera…

For full eligibility, visit ClinicalTrials.gov.

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