RecruitingNot ApplicableNCT06402188

ColoSeal™ ICD System Safety and Feasibility Study

European ColoSeal™ ICD System Safety and Feasibility Study


Sponsor

Averto Medical, Inc.

Enrollment

15 participants

Start Date

Jun 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and feasibility of a new device called the ColoSeal ICD System, designed to help protect bowel connections (anastomoses) from leaking after surgery to remove rectal or colon cancer. Anastomotic leaks are a serious complication of this type of surgery. **You may be eligible if...** - You are 18–65 years old (up to 70 with limited other health conditions) - You have been diagnosed with rectal or rectosigmoid colon cancer - You are scheduled for elective bowel resection surgery with creation of a bowel reconnection and a temporary protective stoma **You may NOT be eligible if...** - Your life expectancy is less than 1 year - You have serious health conditions (ASA classification above 3) or very low albumin - You have an active infection, bleeding disorder, or immune suppression - Your BMI is 40 or higher - You have had pelvic bowel surgery before - You are pregnant or planning to become pregnant - You have an allergy to iodine or components of the device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEColoSeal ICD Device

The subject will undergo scheduled resection per the surgeon's preferred technique. Following completion of the anastomosis, the Intraluminal Colonic Diversion (ICD) Device will be inserted, advanced and positioned with the ICD Delivery System transanally. The ICD Device will remain in place for 10± 2 days. Anastomotic leak testing will be performed prior to scheduled removal.


Locations(3)

National Center of Oncology after V.A. Fanarjian

Yerevan, Armenia

Israeli-Georgian Medical Research Clinic Healthycore

Tbilisi, Georgia

National Cancer Institute

Tashkent, Uzbekistan

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NCT06402188


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