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

Part of paid clinical trials in Buffalo, New York.

Sponsor
JSR Medical Co., Ltd.
Study ID
NCT05826743
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • COLO BT™ — DEVICE
    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)
  • Stoma Creation — OTHER
    Protective ileostomy

Study Details

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)

Key Dates

Start date
Dec 4, 2023
Status verified
Jun 2025
Primary completion
Dec 15, 2026
Completion
Mar 15, 2027

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: COLO BT™
    Patients receive COLO BT™ during colorectal surgery.
  • Active Comparator: Standard of Care
    Patients receive the standard of care, a protective stoma, during colorectal surgery.

Primary Outcome Measure

Study Success Case(Avoidance of ostomy) [ Time Frame: 24 Weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Jacobs School of Medicine & Biomedical Sciences, State University of New York at BuffaloBuffaloNew York14203
Kim
[email protected]
716-480-7627
PennState Health - Milton S. Hershey Medical CenterHersheyPennsylvania17033
Damaris
[email protected]
717-531-0003
Baylor College of MedicineHoustonTexas77030
Hector
[email protected]
915-271-7135

Find similar trials in Buffalo, NY

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo· Buffalo, NYPennState Health - Milton S. Hershey Medical Center· Hershey, PABaylor College of Medicine· Houston, TX

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