RECRUITING

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

Conditions

Colorectal Surgery Colorectal Cancer Rectal/Anal Stoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

Safety and Effectiveness Evaluations of the COLO-BT™ (Colorectal Balloon Tube) as an Alternative Treatment to the Temporary Ileostomy Following Proctectomy.

Quick Facts

Study Start:2023-12-04

Study Completion:2025-06-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05826743

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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).	* Women who are pregnant or breastfeeding * Those who receive emergency surgery * A person who is expected to need intensive medical care after the surgery due to a serious medical condition, with one or more of the following seven factors being true: * Patients with abnormal bone marrow function (those with hemoglobin less than 10g/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 Anaesthesiologists) 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. * 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 mental retardation. * Patients with intestinal perforation, abscess in the pelvis, or severe inflammation in the pelvis. * Those who have a history of undergoing major surgeries (bowel/gastrectomy, hepatectomy, hysterectomy) through laparotomy and are likely to have serious adhesions that may affect this surgery. * 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. * Patients with inflammatory bowel diseases such as ulcerative colitis, Crohn's disease, intestinal tuberculosis, or autoimmune diseases such as Behcet's disease.

Inclusion Criteria

Exclusion Criteria

* 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).

* Women who are pregnant or breastfeeding
* Those who receive emergency surgery
* A person who is expected to need intensive medical care after the surgery due to a serious medical condition, with one or more of the following seven factors being true:
* Patients with abnormal bone marrow function (those with hemoglobin less than 10g/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 Anaesthesiologists) 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.
* 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 mental retardation.
* Patients with intestinal perforation, abscess in the pelvis, or severe inflammation in the pelvis.
* Those who have a history of undergoing major surgeries (bowel/gastrectomy, hepatectomy, hysterectomy) through laparotomy and are likely to have serious adhesions that may affect this surgery.
* 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.
* Patients with inflammatory bowel diseases such as ulcerative colitis, Crohn's disease, intestinal tuberculosis, or autoimmune diseases such as Behcet's disease.

Contacts and Locations

Study Contact

Kim

CONTACT

+82-10-9345-1058

jakehykim@jsrmed.co.kr

Study Locations (Sites)

Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo

Buffalo, New York, 14203

United States

PennState Health - Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: JSR Medical Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-04

Study Completion Date2025-06-15

Study Record Updates

Study Start Date2023-12-04

Study Completion Date2025-06-15

Terms related to this study

Keywords Provided by Researchers

Colorectal Surgery
Colorectal Cancer
Stoma

Additional Relevant MeSH Terms

Colorectal Surgery
Colorectal Cancer
Rectal/Anal