A balloon tube that could spare patients a stoma after bowel surgery

NCT ID NCT05826743

Recruiting now Disease control Sponsor: JSR Medical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial is testing a device called COLO-BT™, a temporary balloon tube placed inside the bowel after colorectal surgery. The goal is to see if it can safely divert stool away from the surgical connection, potentially avoiding the need for a temporary ileostomy (a stoma bag). The study includes adults aged 19-80 who are undergoing colorectal surgery and compares the outcomes of those using the device with those receiving a standard protective stoma. Success is measured by whether patients avoid a stoma and have no major complications over six months.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: COLO-BT™, a temporary intraluminal bypass device (a balloon tube placed inside the bowel to divert stool away from the surgical connection)
What this could lead to: If effective, this device could offer a stoma-free recovery for many colorectal surgery patients, avoiding the need for a temporary ileostomy and its associated burdens.
What could go wrong: The device is still being tested, and its safety and effectiveness are not yet established. There is a risk of complications such as device migration, blockage, or failure to prevent leakage, and not all patients may be suitable candidates.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for ANASTOMOTIC LEAKAGE are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Anastomotic Leak colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ANASTOMOTIC LEAKAGE COLORECTAL CANCER COLORECTAL SURGERY ILEOSTOMY - STOMA RECTAL/ANAL

Contacts and locations

Locations

Baylor College of Medicine
RECRUITING

Houston, Texas, 77030, United States
Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo
RECRUITING

Buffalo, New York, 14203, United States
PennState Health - Milton S. Hershey Medical Center
RECRUITING

Hershey, Pennsylvania, 17033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.