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RECRUITING
NCT04184973
NA

Efficacy and Safety of the CG-100 Intraluminal Bypass Device

Sponsor: Colospan Ltd.

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

22 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2020-06-23

Completion Date

2026-12-31

Last Updated

2025-10-23

Healthy Volunteers

No

Interventions

DEVICE

CG-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)

PROCEDURE

Stoma

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