Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System
2 other identifiers
observational
80
7 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2010
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedFirst Posted
Study publicly available on registry
April 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedSeptember 18, 2013
September 1, 2013
1.2 years
March 29, 2010
September 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relief of obstruction
At the Conclusion of the Procedure
Secondary Outcomes (3)
Implant Duration
6 months
Symptoms at Follow-up
6 months
Complications
6 months
Study Arms (1)
Stent Group
Interventions
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.
Eligibility Criteria
Referral Centers
You may qualify if:
- colonic strictures caused by malignant neoplasms, and
- large bowel obstruction due to malignant strictures prior to colectomy.
You may not qualify if:
- central ischemia,
- any contraindication to GI endoscopy and any procedure to be performed in conjunction with stent placement,
- suspected or impending perforation,
- intra-abdominal abscess/perforation,
- inability to pass wire guide or stent deployment system through the obstructed area,
- patients for whom endoscopic or percutaneous procedures are contraindicated,
- benign disease, and
- coagulopathy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Kingston General Hospital
Kingston, Ontario, K7L5G2, Canada
St. Michael's Hospital
Toronto, Ontario, M5B1N8, Canada
Odense Universitetshospital
Odense, 5000, Denmark
Institut Paoli Calmettes
Marseille, 13009, France
Instituto Clinico Humanitas IRCCS
Milan, 20089, Italy
Deventer Ziekenhuis
Deventer, 7416 SE, Netherlands
Hospital de Basurto
Bilbao, Bilbao, 48013, Spain
Hospital Universitari de Girona
Girona, 17007, Spain
Hospital Son Llatzer
Palma de Mallorca, 48013, Spain
University College of London Hospital
London, NW 1 2BU, United Kingdom
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2010
First Posted
April 13, 2010
Study Start
April 1, 2010
Primary Completion
July 1, 2011
Study Completion
February 1, 2012
Last Updated
September 18, 2013
Record last verified: 2013-09