Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

Completed

• Conditions: Colonic Obstruction; Colonic Stricture; Large Bowel Obstruction

• Registration Number: NCT01102283
• Lead Sponsor: Cook Group Incorporated

Brief Summary

The objective of this registry is to compile clinical data on the use of the Evolution® Colonic Stent System for the palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-29
• Study Start: 2010-04
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Primary Completion: 2011-07
• Study Completion: 2012-02
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief of obstruction	At the Conclusion of the Procedure

Secondary Outcome Measures

Name	Time	Method
Implant Duration	6 months
Symptoms at Follow-up	6 months
Complications	6 months	perforation, migration, obstruction, GI bleeding requiring intervention

Trial Locations

Locations (10)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Odense Universitetshospital; 🇩🇰 Odense, Denmark

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Instituto Clinico Humanitas IRCCS; 🇮🇹 Milan, Italy

Deventer Ziekenhuis; 🇳🇱 Deventer, Netherlands

Hospital de Basurto; 🇪🇸 Bilbao, Spain

Hospital Universitari de Girona; 🇪🇸 Girona, Spain

Hospital Son Llatzer; 🇪🇸 Palma de Mallorca, Spain

University College of London Hospital; 🇬🇧 London, United Kingdom