Actively Recruiting
ColoSeal™ ICD System Safety and Feasibility Study
Led by Averto Medical, Inc. · Updated on 2025-11-04
15
Participants Needed
3
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical investigation is to evaluate the safety and feasibility of the ColoSeal ICD System in a prospective, multicenter, single-arm study. The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis, anastomosis leak, or perforation from contact with fecal flow for up to 21 days. The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis.
CONDITIONS
Official Title
ColoSeal™ ICD System Safety and Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years, or 66 to 70 years with up to one controlled cardiovascular, metabolic, or pulmonary condition
- Diagnosed with rectosigmoid or rectal cancer
- Scheduled for elective open, laparoscopic, or robotic resection with mesorectal excision and protective ostomy
- Creation of an anastomosis no more than 15 cm from the anal verge
- Provided informed consent approved by Ethics Committee or Institutional Review Board
- Willing and able to follow study procedures and visits
You will not qualify if you...
- Life expectancy less than 1 year
- ASA classification greater than 3
- Albumin level below 30 g/liter
- Current local or systemic infection
- Major surgery or interventions within 30 days before study or planned within 1 month after
- Systemic chemotherapy or pelvic radiation within 30 days before planned procedure
- 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 of 40 or higher
- Scheduled for concurrent major surgery (e.g., liver resection)
- Regular use of systemic or steroid medications in past 3 months
- Use of antimetabolite or antiplatelet agents
- Prior pelvic anastomosis
- Requires an anastomosis smaller than 31 mm in diameter
- Known allergy to device components, iodine, or iodine-based contrast
- Any condition that may risk safety or data quality as judged by the investigator
- Pregnant or planning pregnancy; females must have a negative pregnancy test within 7 days before surgery
- Unable or unwilling to give informed consent
- Currently in another investigational drug or device study that interferes with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
K
Kenton Fong, MD
CONTACT
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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