NCT05826743

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: JSR Medical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Accepted

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)

Detailed description

A primary diverting stoma is widely used by surgeons in order to bypass low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which mean that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit. COLO BT™ is a local, temporary bypass device that provides protection of the anastomosis and safely postpones stoma. COLO BT™ is designed to avoid stoma creation in all patients except those patients whose anastomoses have not healed after surgery, allowing the others to return to normal activity more quickly and safely.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-04
• Primary completion: 2026-12-15
• Completion: 2027-03-15
• First posted: 2023-04-24
• Last updated: 2025-06-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study