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

NCT05826743 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2025-06-13

No results posted yet for this study

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)

Conditions

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

Sponsors & Collaborators

  • JSR Medical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Mark A Falvo, MD · Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2026-12-15
Completion
2027-03-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05826743 on ClinicalTrials.gov