Actively Recruiting
European ColoSeal ICD System Safety and Feasibility Study for Rectal and Rectosigmoid Cancer
Led by Averto Medical, Inc. · Updated on 2025-11-04
15
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and feasibility of the ColoSeal ICD System in adult patients with rectal and rectosigmoid cancer who are undergoing surgery to remove part of the colon and create a colorectal anastomosis. The study is a prospective, multicenter, single-arm clinical investigation focusing on protecting damaged colon segments, such as surgical anastomoses or leaks, from contact with fecal flow for up to 21 days. Participants will have scheduled colon resection surgery using the surgeon's preferred method. After completing the anastomosis and confirming no leaks, the ColoSeal ICD Device will be inserted transanally and positioned with an anchoring portion placed in healthy bowel above the site needing protection. The device will remain in place for about 10 days, secured externally with adhesive dressings, and removed after confirming no anastomotic leaks. During the study, participants will be monitored through various assessments including leak tests before device insertion and removal. Researchers will track device-related adverse events up to 90 days post-procedure and measure procedure success, procedure time, device migration, occurrence of anastomotic leaks, need for ostomy surgery, and successful device removal. The study duration includes follow-up for up to 90 days after the procedure to ensure safety and device feasibility.
CONDITIONS
Brief Title
ColoSeal™ ICD System Safety and Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is 18-65 years old, or 66-70 years old with up to one controlled cardiovascular, metabolic, or pulmonary condition
- Diagnosed with rectosigmoid or rectal cancer
- Scheduled for elective colon surgery requiring an anastomosis with protective ostomy (anastomosis within 15 cm of anal verge)
- Informed consent provided according to ethics approval
- Willing and able to comply with study follow-up requirements
You will not qualify if you...
- Life expectancy less than 1 year
- ASA physical status classification greater than 3
- Albumin level below 30 g/liter
- Local or systemic infection at time of intervention
- Major surgery or intervention within 30 days before or planned within 1 month after study entry
- Received chemotherapy or pelvic radiation within 30 days before planned surgery
- Diagnosed with bowel obstruction, strangulation, peritonitis, perforation, ischemic bowel, carcinomatosis, diverticulitis, or widespread inflammatory bowel disease
- Diagnosed with coagulopathy, thrombocytopenia, or immune suppression
- Body mass index (BMI) of 40 or higher
- Scheduled for concurrent major surgery such as liver resection
- Regular systemic or steroid medication use in last 3 months
- Taking antimetabolites or antiplatelet agents
- Prior pelvic anastomosis
- Requires an anastomosis smaller than 31 mm diameter
- Known allergy to device components or iodine-based contrast
- Any condition that may risk safe participation or data quality
- Pregnant or planning pregnancy; must have negative pregnancy test if of childbearing potential
- Unable or unwilling to provide informed consent
- Currently participating in conflicting investigational drug or device studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus 10 ± 2 days post-operatively
Participants undergo scheduled colon resection surgery with colorectal anastomosis, followed by transanal placement of the ColoSeal ICD Device to protect the anastomosis from fecal flow.
1 surgical procedure and device placement visit; device remains in place for approximately 10 days
Duration - Up to 90 days post procedure
Participants have the ColoSeal ICD Device removed after confirming no anastomotic leak, with monitoring for device-related safety and procedure success for up to 90 days post procedure.
Follow-up visits as needed up to 90 days
Trial Site Locations
Total: 3 locations
1
National Center of Oncology after V.A. Fanarjian
Yerevan, Armenia
Actively Recruiting
2
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia, 0112
Completed
3
National Cancer Institute
Tashkent, Uzbekistan
Actively Recruiting
Research Team
G
Grace Carlson, MD
K
Kenton Fong, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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