Recruiting

Testing a protective device for colon surgery recovery

Plain-English translation of NCT06402188 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

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This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This study evaluates the safety and effectiveness of the ColoSeal ICD System, a protective device placed inside the colon during cancer surgery to protect the newly created surgical connection (called an anastomosis) from stool contact. The device is inserted through the rectum without additional incisions and stays in place for about 10–14 days while the surgical site heals. After that time, doctors confirm healing is complete and remove the device.

After surgery to remove rectal or colon cancer, the surgeon must reconnect the healthy sections of colon. This new connection is vulnerable to leaks during early healing, which can lead to serious complications. This trial aims to see whether protecting that area from stool contact can reduce these risks and improve recovery.

Do you qualify?

You likely qualify if…

you are between 18 and 70 years old
you have been diagnosed with rectal or rectosigmoid cancer and are scheduled for surgical removal
your surgery will create a new connection (anastomosis) in the colon that is less than 15 cm from the anal opening
you are willing and able to attend follow-up visits and comply with study requirements
you have given written informed consent and understand the study procedures

You likely don't qualify if…

you have a life expectancy of less than one year
you have had chemotherapy or radiation to the pelvis in the last 30 days
you have a blood clotting disorder or are taking certain blood-thinning medications (except aspirin)
you have had recent major surgery or are planning another major surgery within one month
you have a BMI of 40 or higher, or other serious medical conditions that would make surgery risky

What participation looks like

You will undergo your planned colon cancer surgery as scheduled. During surgery, after the surgeon creates the new connection, the ColoSeal device will be inserted through the rectum and positioned to protect the surgical site. The device has an external collection bag attached to your skin to gather stool. You will keep the device in place for about 10 days while you recover at home, then return to the hospital for a healing check. Once the surgeon confirms the surgical site has healed properly, the device is removed in a simple outpatient procedure.

AI-generated summary from trial data · Jun 29, 2026 · Not medical advice

Trial locations(3 sites)

Armenia

National Center of Oncology after V.A. Fanarjian, Yerevan

Georgia

Israeli-Georgian Medical Research Clinic Healthycore, Tbilisi

Uzbekistan

National Cancer Institute, Tashkent