BridgeMD
Tests treatment safety and results for Colorectal Surgery
Official title Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
ClinicalTrials.gov ID: NCT05826743
What this study is testing
- What it's testing
- 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)
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80. Healthy volunteers may be eligible.
You may be able to join if
- The patient must meet all study 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...
You likely can't join if
- 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...
- Patients with abnormal bone marrow function (those with hemoglobin less than 7g/dl, leukocyte count less than 4000/mm3, or platelet count less than...
- Patients with severe liver damage or cirrhosis (those whose AST/ALT levels are more than three times the normal range or those diagnosed with...
See the full eligibility criteria
Who can join
- The patient must meet all study 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 to be eligible. While not...
What rules you out
- 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 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 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...
- 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 intellectual disability.
- Patients with intestinal perforation, abscess in the pelvis, or severe inflammation in the pelvis.
- 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.
- 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...
- Patients who had pre-operative radiotherapy should be excluded.
- Patients with inflammatory bowel diseases such as ulcerative colitis, Crohn's disease, intestinal tuberculosis, or autoimmune diseases such as Bechet's disease.
- Those who do not consent in writing to the study.
- Experienced blood loss (\>750 cc) within 6 weeks before randomization.
- Transfusion during surgery.
- Any new sign of ischemia within 6 weeks before randomization.
- Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel all due to carcinomatosis within 6 weeks before randomization.
- Known hypersensitivity or allergy to any of the components required for the procedure.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
- Hershey, Pennsylvania, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States; Hershey, Pennsylvania, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.