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Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery

NCT02109991 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-12-08

No results posted yet for this study

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).

Conditions

  • Gastrointestinal Anastomosis

Interventions

DEVICE

CG-100 device

Colorectal surgery performed per standard of care with deployment of the CG-100 device in the anastomosis site

Sponsors & Collaborators

  • Colospan Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • Belgium
  • Croatia
  • Hungary
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02109991 on ClinicalTrials.gov