RecruitingNot ApplicableNCT04184973

Efficacy and Safety of the CG-100 Intraluminal Bypass Device

Efficacy and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized Trial

Sponsor

Colospan Ltd.

Enrollment

250 participants

Start Date

Jun 23, 2020

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer Rectal Tumor Rectal/Anal

Summary

A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.

Eligibility

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and effectiveness of the CG-100, a device placed inside the colon during surgery that acts as a temporary internal bypass, helping the bowel heal after cancer surgery and reducing the risk of complications like leakage at the surgical join. **You may be eligible if...** - You have been diagnosed with colorectal cancer - You are 22–65 years old (or up to 70 with at most one additional health condition requiring medication) - You are scheduled for elective colorectal surgery (open or laparoscopic/robotic) - You are willing to attend follow-up visits **You may NOT be eligible if...** - You are having emergency surgery - You have inflammatory bowel disease (Crohn's or ulcerative colitis) - You have a colostomy or ileostomy - You are undergoing abdominoperineal resection (removal of the rectum and anus) 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

DEVICECG-100 intraluminal bypass device

a removable, temporary intraluminal bypass device, developed by Colospan, is designed to safely postpone the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis)

PROCEDUREStoma

Primary protective ileostomy

Locations(14)

University of California Irvine

Orange, California, United States

Kaiser Permanente San Diego medical Center

San Diego, California, United States

Colorado University Anschutz Medical Campus

Aurora, Colorado, United States

University of Louisville

Louisville, Kentucky, United States

Henry Ford Health System

Detroit, Michigan, United States

East Bank Hospital - M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, United States

New York-Presbyterian / Weill Cornell Medical Center

New York, New York, United States

Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Lifespan & Brown Surgical Associates

Providence, Rhode Island, United States

University of Utah Health

Salt Lake City, Utah, United States

Soroka University Medical Center

Beersheba, Israel

Carmel Medical Center

Haifa, Israel

Rabin Medical Center

Petah Tikva, Israel

Humanitas Research Hospital

Milan, Lombardy, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04184973

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