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

NCT05826743

This study is recruiting at 3 US sites in 3 states, according to its ClinicalTrials.gov record last updated .

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)

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Colorectal Surgery
  • Colorectal Cancer
  • Rectal/Anal
  • Ileostomy - Stoma
  • Anastomotic Leakage

Eligibility basics and study details

Study type
Interventional
Phase
Not applicable
Ages
19 to 80 years
Sex
All
Healthy volunteers
Accepted
Sponsor
JSR Medical Co., Ltd.
Last updated on ClinicalTrials.gov
August 5, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

New York · 1

  • Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo · Buffalo, NY

Pennsylvania · 1

  • PennState Health - Milton S. Hershey Medical Center · Hershey, PA

Texas · 1

  • Baylor College of Medicine · Houston, TX

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.