NCT05826743View on ClinicalTrials.gov

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

NARecruitingINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

December 4, 2023

Primary Completion Date

December 15, 2026

Study Completion Date

March 15, 2027

Conditions
Colorectal SurgeryColorectal CancerRectal/AnalIleostomy - StomaAnastomotic Leakage
Interventions
DEVICE

COLO 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)

OTHER

Stoma Creation

Protective ileostomy

Trial Locations (3)

14203

RECRUITING

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

17033

RECRUITING

PennState Health - Milton S. Hershey Medical Center, Hershey

77030

RECRUITING

Baylor College of Medicine, Houston

All Listed Sponsors
lead

JSR Medical Co., Ltd.

INDUSTRY