Colorectal Cancer Clinical Trial
— COLO-BTOfficial title:
Safety and Effectiveness Evaluations of the COLO-BT™ (Colorectal Balloon Tube) as an Alternative Treatment to the Temporary Ileostomy Following Proctectomy.
NCT number | NCT05826743 |
Other study ID # | JSR CB |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 4, 2023 |
Est. completion date | June 15, 2025 |
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)
Status | Recruiting |
Enrollment | 256 |
Est. completion date | June 15, 2025 |
Est. primary completion date | March 15, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 80 Years |
Eligibility | 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). ? One or more of the following six risk factors for postoperative anastomotic leakage6-8 must be true: - 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 tumours - Those who received chemo/radiation therapy before surgery ? Those who voluntarily decide to participate in this clinical study, read and sign the Informed Consent form, and are willing to comply with the study protocol ? 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: - 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. ? 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 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. ? Those who do not consent in writing to the study. ? Blood loss (>750 cc). ? Transfusion during surgery. ? Any new sign of ischemia. ? Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, carcinomatosis. ? Exclusion criteria not specified above, but the patient is determined to be unsuitable for participation in this clinical study at the judgment of the researcher. |
Country | Name | City | State |
---|---|---|---|
United States | Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo | Buffalo | New York |
United States | PennState Health - Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Baylor College of Medicine | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
JSR Medical Co., Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Study Success Case(Avoidance of ostomy) | 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 | 24 Weeks |
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