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COLO-BT for Colorectal Surgery to Avoid Ileostomy

This study is looking at a device called COLO-BT™ as an alternative to creating a protective ileostomy (a surgical opening in the belly to divert waste) after colorectal surgery. The COLO-BT™ is a temporary, removable device placed inside the intestine. It's designed to keep stool away from the surgical site, helping it heal and potentially avoiding the need for a permanent ileostomy. The study aims to see if using COLO-BT™ can successfully help patients avoid an ileostomy. You may be able to join if you are between 19 and 80 years old and your surgery involves a specific part of the rectum (between 4cm and 15cm from the anus). The study plans to enroll 256 participants, but its current status is unclear.

Study design
This is an interventional study comparing the COLO-BT™ device to standard ileostomy creation, with a planned enrollment of 256 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at 24 weeks after treatment.

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NCT05826743

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

Recruiting
NAAges 19–80InterventionalTreatment
JSR Medical Co., Ltd.
~256 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:COLO BT™Stoma Creation

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Study Success Case(Avoidance of ostomy)
Measured over 24 Weeks

Conditions

Colorectal Surgery
Colorectal Cancer
Rectal/Anal
Ileostomy - Stoma
Anastomotic Leakage

Explore related trials

Colorectal Carcinoma

Where it's being run

3 sites across 3 states
New York1
Pennsylvania1
Texas1

Study leadership

  • Mark A Falvo, MD · PRINCIPAL_INVESTIGATOR · Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo

Who to contact

Kim
[email protected]
+82-10-9345-1058
Email the study team

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Eligibility criteria

Inclusion

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).

Exclusion

Patients with abnormal bone marrow function (those with hemoglobin less than 7g/dl, leukocyte count less than 4000/mm3, or platelet count less than 100,000/mm3 even after preoperative corrections)
Patients with severe liver damage or cirrhosis (those whose AST/ALT levels are more than three times the normal range or those diagnosed with cirrhosis)
Those with abnormal renal function (those who are on hemodialysis or who have a blood creatinine level of 2.0mg/dl or more before the surgery)
Those who have undergone cardiac or cerebrovascular stent procedure within the last 6 months
Those who have been diagnosed with pulmonary tuberculosis within the last 6 months or are undergoing drug treatment for pulmonary tuberculosis
Those who continuously administer steroids of 20mg/day or more within 30 days before the surgery
Patients with ASA (American Society of Anesthesiologists) score of 3 are evaluated by the investigator who determines whether or not patients with ASA score of 3 should be enrolled from the patient safety standpoint. Patients with ASA score higher than 3 are excluded from this study.
Patients who are required to undergo re-intervention to treat the anastomosis following intraoperative positive air leak test (However, patients who underwent complete reconstruction of the anastomosis in the presence of a positive air test, which therefore has made their risk of leak similar to those patients with a negative air leak test.)
Patients who are immune suppressed
Patients with severe diverticulosis
Patients with other colonic wall abnormalities in the likely area of the Outer Balloon and BT BAND application who may be at increased risk for device perforation or migration. 4. A person who has difficulty in mobility or is unable to communicate in general due to a psychiatric/neurologic disorder falling under one or more of the following:
Those diagnosed with dementia or Alzheimer's disease.
Those who have been diagnosed with schizophrenia or depression or are taking drugs due to this.
A person who has been diagnosed with disability due to intellectual disability. 5. Patients with intestinal perforation, abscess in the pelvis, or severe inflammation in the pelvis. 6. Those who have a history of undergoing major surgeries (major bowel resection/major gastrectomy, major hepatectomy) through laparotomy and are likely to have serious adhesions that may affect this surgery. 7. A patient who underwent a preoperative chemotherapy, but the anastomosis is expected to be located very close to the anus or in the anal canal, thus with a very high risk for complications of the anastomosis, or a patient whom the bowel function is expected to decrease significantly in the future. 8. Patients who had pre-operative radiotherapy should be excluded. 9. Patients with inflammatory bowel diseases such as ulcerative colitis, Crohn's disease, intestinal tuberculosis, or autoimmune diseases such as Bechet's disease. 10. Those who do not consent in writing to the study. 11. Experienced blood loss (\>750 cc) within 6 weeks before randomization. 12. Transfusion during surgery. 13. Any new sign of ischemia within 6 weeks before randomization. 14. Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel all due to carcinomatosis within 6 weeks before randomization. 15. Known hypersensitivity or allergy to any of the components required for the procedure.

What this trial measures

  • Study Success Case(Avoidance of ostomy)24 Weeks

    Study Success Case" is defined as a case which has met both the "Clinical Success" and "Technical Success" requirements throughout the 24 weeks (6 Months) monitoring period, following the initial surgical treatment with COLO-BT™ or temporary ileostomy