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NCT05826743 · ClinicalTrials.gov record · last posted 2026-08-05

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

Study acronym: COLO-BT
StatusRecruiting
PhaseNot applicable
Started2023-12-04
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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)

Protocol amendment history 2 changes detected by DataLookout

2026-08-06
critical
Primary completion pushed: 2026-12-15 → 2027-12-15
2026-08-06
minor
Completion pushed: 2027-03-15 → 2028-03-15
Trial Details
NCT Number NCT05826743
Lead Sponsor JSR Medical Co., Ltd.
Conditions Colorectal Surgery, Colorectal Cancer, Rectal/Anal, Ileostomy - Stoma, Anastomotic Leakage
Enrollment 256 participants
Start Date 2023-12-04
Primary Completion 2027-12-15 (estimated)
Study Completion 2028-03-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-05