Evaluation of the ColoSeal ICD System for protecting colon surgery sites
European ColoSeal™ ICD System Safety and Feasibility Study
NA · Averto Medical, Inc. · NCT06402188
This study is testing a new device that helps protect the surgical sites in the colon of adults with rectal cancer after their surgery to see if it keeps them safe from complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Averto Medical, Inc. (industry) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Yerevan and 2 other locations) |
| Trial ID | NCT06402188 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to assess the safety and feasibility of the ColoSeal ICD System in a multicenter, single-arm format. The device is designed to protect damaged segments of the colon, such as surgical anastomoses, from fecal flow for up to 21 days. Adult patients with rectal and rectosigmoid cancer undergoing resection with a colorectal anastomosis will be the focus of this study. After the anastomosis is completed and confirmed leak-free, the ColoSeal ICD Device will be inserted transanally to provide protection during the critical postoperative period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 diagnosed with rectosigmoid or rectal cancer scheduled for elective resection requiring an anastomosis.
Not a fit: Patients with a life expectancy of less than one year or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly reduce complications related to anastomosis leaks in colorectal cancer surgeries.
How similar studies have performed: While the specific use of the ColoSeal ICD System is novel, similar protective devices have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject is 18-65 years of age at screening, or subject is 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed. * Subject is diagnosed with rectosigmoid or rectal cancer * Subject is scheduled for elective resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis and protective ostomy (anastomosis maximally 15 cm from the anal verge). * The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB). * Subject must be willing and able to comply with study follow-up requirements. Exclusion Criteria: * Subject with a life expectancy \< 1 year * Subjects with ASA classification \> 3 * Albumin \< 30 g/liter * Subject has local or systemic infection at the time of intervention. * Major surgical or interventional procedures within 30 days prior to this study or planned major surgical or interventional procedures within 1 month of entry into this study * Patient has received systemic chemotherapy or radiation to the pelvis within 30 days prior to the planned procedure * Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, diverticulitis, or extensively spread inflammatory bowel disease * Subjects has a diagnosis of coagulopathy, thrombocytopenia, immune suppression * BMI ≥ 40 * Subject is scheduled for a concurrent major surgical procedure during the surgery (e.g., liver resection) * Subject has been taking regular systemic/ steroid medication in the last 3 months * Subjects is taking antimetabolites or antiplatelet agents * Subject has undergone a prior pelvic anastomosis * Subject requires an end-to-end anastomosis smaller than 31 mm in diameter * Known allergy to any component of the device * Known allergy to iodine or iodine-based contrast * Any condition or abnormality which in the opinion of the investigator may jeopardize the subject's safe participation or the quality of the data * Subject is pregnant or planning to become pregnant. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure * Subject is unable or unwilling to provide informed consent * Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints
Where this trial is running
Yerevan and 2 other locations
- National Center of Oncology after V.A. Fanarjian — Yerevan, Armenia (RECRUITING)
- Israeli-Georgian Medical Research Clinic Healthycore — Tbilisi, Georgia (COMPLETED)
- National Cancer Institute — Tashkent, Uzbekistan (RECRUITING)
Study contacts
- Principal investigator: Hurshid Djamshidovich, MD — National Cancer Institute Tashkent Uzbekistan
- Study coordinator: Grace Carlson, MD
- Email: grace.carlson@avertomed.com
- Phone: 1-415-518-7043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer, Colon anastomosis, Rectosigmoid cancer resection, Ostomy, Colon diversion