COLO-BT Device for Colorectal Surgery

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

Recruiting N/A Interventional Study
Colorectal Surgery Colorectal Cancer Rectal/Anal Ileostomy - Stoma Anastomotic Leakage
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
19 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
256 (estimated)
Sponsor
JSR Medical Co., Ltd. · Industry
Who this trial is looking for

This trial is looking for adults aged 19 to 80 years who have had colorectal surgery. Participants will use a temporary device to help improve recovery after surgery.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 19 and 80 years old.
  • I have signed the consent form.
  • My anastomosis is above 4cm and at or below 15cm from my anus.
  • I am willing to participate in follow-up evaluations.
  • I am willing to have a blood transfusion if necessary.

You may not be able to join if

  • I am pregnant or breastfeeding.
  • I need emergency surgery.
  • I have severe liver damage or cirrhosis.
  • I have abnormal kidney function.
  • I have been diagnosed with certain psychiatric disorders.
  • I have had major surgeries that may cause serious adhesions.
  • I have had recent chemotherapy or radiotherapy.
  • I do not consent in writing to this study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

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)

Trial Locations
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Eligibility Criteria
Inclusion Criteria: The patient must meet all study Inclusion Criteria as outlined below: * Adult males or females, 19-80 years of age, with signed informed consent * Subject whose anastomosis is expected to be located above 4cm from the anus, and at or below 15cm from the anus. (4cm \< inclusi…
Contacts

Kim

+82-10-9345-1058

jakehykim@jsrmed.co.kr

CONTACT