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Safety and Performance of the CG-100 in Patients Undergoing Colorectal Surgery.

Colorectal Surgery Clinical Trial

Official title:
A Prospective, Multi-center, Single-arm, Open-label Study Designed to Evaluate Safety and Performance Profile of the CG-100 Intraluminal Bypass Device in Patients Undergoing Colorectal Surgery

Clinical Trial Summary

The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)

Clinical Trial Description

Colospan is initiating a pivotal clinical prospective, multi-center, single-arm, open-label study designed to evaluate safety and performance profile of the CG-100 Intraluminal Bypass Device in patients undergoing colorectal surgery study.

Up to 137 patients (in total) will be enrolled in up to 12 sites in Europe, Israel and USA.

Study objectives Primary Objective: To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic) Secondary Objectives: To evaluate Performance in terms of clinical and radiological anastomotic leakage Successful positioning and maintenance of device position To assess the ease of the device's application and removal Safety: To assess the safety profile of the CG-100 Intraluminal Bypass Device. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03423485
Study type Interventional
Source Colospan Ltd.
Contact Ilia Pinsk, MD
Phone +972-8-6400561
Email IliaPi@clalit.org.il
Status Recruiting
Phase N/A
Start date January 1, 2018
Completion date July 31, 2019
View Details
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