← 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

COLO-BT Trial 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.Check my eligibility

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.See study design

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.

COLO-BT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Study Success Case(Avoidance of ostomy)

COLO-BT 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

JSR Medical Co., Ltd.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accommodate individuals who are octogenarians?

"The study mandates that potential participants must be between 19 and 80 years old to qualify for inclusion."

Answered by AI

Am I able to join this experiment?

"This experiment is open to participants between the ages of 19 and 80 that have recently undergone colorectal surgery. A total of 256 enrollees are needed for this study."

Answered by AI

What is the maximum capacity for participants in this clinical research?

"256 individuals conforming to the study's requirements must join this trial. Participants may come from PennState Health - Milton S. Hershey Medical Center in Pennsylvania or Baylor College of Medicine in Texas."

Answered by AI

Are there any remaining vacancies in this research trial?

"Indeed, the data available on clinicaltrials.gov affirms that this medical research is actively enrolling patients. Having been posted on October 4th 2023 and last updated on September 18th 2023, 256 individuals are needed to be recruited from 3 separate healthcare facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Effectiveness Evaluations of the COLO-BT as an Treatment to the Proctectomy.

2023. "Safety and Effectiveness Evaluations of the COLO-BT as an Treatment to the Proctectomy.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05826743.