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Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

Completed
Conditions
Colonic Obstruction
Colonic Stricture
Large Bowel Obstruction
Interventions
Device: Evolution(R) Colonic Stent
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

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
Arm && Interventions
GroupInterventionDescription
Stent GroupEvolution(R) Colonic Stent-
Primary Outcome Measures
NameTimeMethod
Relief of obstructionAt the Conclusion of the Procedure
Secondary Outcome Measures
NameTimeMethod
Implant Duration6 months
Symptoms at Follow-up6 months
Complications6 months

perforation, migration, obstruction, GI bleeding requiring intervention

Trial Locations

Locations (10)

Deventer Ziekenhuis

🇳🇱

Deventer, Netherlands

St. Michael's Hospital

🇨🇦

Toronto, Ontario, Canada

University College of London Hospital

🇬🇧

London, United Kingdom

Hospital Universitari de Girona

🇪🇸

Girona, Spain

Kingston General Hospital

🇨🇦

Kingston, Ontario, Canada

Hospital de Basurto

🇪🇸

Bilbao, Spain

Institut Paoli Calmettes

🇫🇷

Marseille, France

Hospital Son Llatzer

🇪🇸

Palma de Mallorca, Spain

Odense Universitetshospital

🇩🇰

Odense, Denmark

Instituto Clinico Humanitas IRCCS

🇮🇹

Milan, Italy

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