RecruitingNot ApplicableNCT05826743

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

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


Sponsor

JSR Medical Co., Ltd.

Enrollment

256 participants

Start Date

Dec 4, 2023

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the safety and effectiveness of a device called COLO-BT as an alternative to a temporary ileostomy (a surgically created opening in the abdomen for waste) in people who have had bowel surgery in the lower part of the colon or rectum. **You may be eligible if...** - You are 19–80 years old - You are scheduled for bowel surgery where the connection (anastomosis) will be 4–15 cm from the anus - You are willing to participate in follow-up assessments - You are willing to accept a blood transfusion if needed **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are having emergency surgery - You have severely abnormal blood counts (very low haemoglobin, white cells, or platelets) - You have severe liver damage or cirrhosis - You are on dialysis or have very poor kidney function (creatinine above 2.0 mg/dL) - You have other serious conditions that would require intensive post-operative care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Buffalo

Buffalo, New York, United States

PennState Health - Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05826743


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