Recruiting nowNot phasedRandomised
What this trial is trying to do
The researchers are testing whether COLO-BT™, a temporary tube placed inside the bowel, can divert stool away from the surgical join (anastomosis) after colorectal surgery. The aim is to provide protection without creating a diverting ileostomy, a stoma that brings the small bowel through the abdominal wall.
The comparison is standard stoma creation, and the main measure is whether an ostomy can be avoided. The trial therefore asks whether this device can protect the bowel join while allowing more patients to avoid a temporary stoma; the record does not specify other benefits such as fewer complications or longer survival.
Worth knowing: This is a randomised device trial whose stated main outcome is ostomy avoidance, not survival or cancer control.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT05826743 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, open label |
| Taking part | 256 people (planned) |
| Who can join | aged 19 Years to 80 Years |
| Run by | JSR Medical Co., Ltd. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Device COLO BT™
- Other Stoma Creation
What it is measuring
Study Success Case(Avoidance of ostomy)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
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)
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
- Rectal
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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 < inclusion target ≤ 15cm from the anus).
③ Patient must meet all other inclusion criteria to be eligible. While not required, if one or more of the following six risk factors for postoperative anastomotic leakage[6,7,8] is true, the patient will be considered a high-risk subject:
- Male
- Those with a body mass index of 30 or higher
- Current smoker
- Those who are on medication for diabetes
- Those with clinical stage III or higher malignant tumors
- Those who received chemo/radiation therapy before surgery
④ Those who are willing and able to participate in this clinical study, provide Informed Consent, and are willing to comply with the study procedures and follow up evaluations
⑤ Those who have willingness to undertake blood transfusion if required.
Exclusion Criteria
Patients meeting any of the following Exclusion Criteria will not be eligible to participate in the study:
1. Women who are pregnant or breastfeeding
2. Those who receive emergency surgery
3.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 3 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT05826743, registered by JSR Medical Co., Ltd. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.