← Back to Search

Intraluminal Bypass Device

COLO BT™ Device for Colorectal Surgery Recovery (COLO-BT Trial)

N/A
Recruiting
Research Sponsored by JSR Medical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial studies a device that can reduce contact between fecal matter and an anastomotic site after colorectal surgery, helping patients heal faster and better.

Who is the study for?
Adults aged 19-80 needing colorectal surgery with anastomosis between 4-15cm from the anus. Must have one risk factor like obesity, smoking, diabetes, stage III+ cancer, or pre-surgery chemo/radiation. Excludes those with severe medical conditions, recent major surgeries affecting the area, emergency surgery needs, pregnant/breastfeeding women, and certain blood disorders.
What is being tested?
The COLO-BT™ device is being tested to see if it can reduce complications after colorectal surgery by preventing fecal matter from contacting the surgical site. Participants will be randomly assigned to use this device or undergo standard stoma creation.
What are the potential side effects?
Potential side effects may include discomfort at the application site of COLO-BT™, possible infection risks due to bypassing fecal content, and general risks associated with colorectal surgical procedures such as bleeding or adverse reactions to anesthesia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Study Success Case(Avoidance of ostomy)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: COLO BT™Experimental Treatment1 Intervention
Patients receive COLO BT™ during colorectal surgery.
Group II: Standard of CareActive Control1 Intervention
Patients receive the standard of care, a protective stoma, during colorectal surgery.

Find a Location

Who is running the clinical trial?

JSR Medical Co., Ltd.Lead Sponsor
~68 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top