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Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

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ClinicalTrials.gov Identifier: NCT01102283
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : September 18, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Colonic Obstruction Colonic Stricture Large Bowel Obstruction Device: Evolution(R) Colonic Stent

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System
Study Start Date : April 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Stent Group Device: Evolution(R) Colonic Stent
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.




Primary Outcome Measures :
  1. Relief of obstruction [ Time Frame: At the Conclusion of the Procedure ]

Secondary Outcome Measures :
  1. Implant Duration [ Time Frame: 6 months ]
  2. Symptoms at Follow-up [ Time Frame: 6 months ]
  3. Complications [ Time Frame: 6 months ]
    perforation, migration, obstruction, GI bleeding requiring intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Referral Centers
Criteria

Inclusion: per the IFU,

  • colonic strictures caused by malignant neoplasms, and
  • large bowel obstruction due to malignant strictures prior to colectomy.

Exclusion:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102283


Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L5G2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1N8
Denmark
Odense Universitetshospital
Odense, Denmark, 5000
France
Institut Paoli Calmettes
Marseille, France, 13009
Italy
Instituto Clinico Humanitas IRCCS
Milan, Italy, 20089
Netherlands
Deventer Ziekenhuis
Deventer, Netherlands, 7416 SE
Spain
Hospital de Basurto
Bilbao, Spain, 48013
Hospital Universitari de Girona
Girona, Spain, 17007
Hospital Son Llatzer
Palma de Mallorca, Spain, 48013
United Kingdom
University College of London Hospital
London, United Kingdom, NW 1 2BU
Sponsors and Collaborators
Cook Group Incorporated

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01102283     History of Changes
Other Study ID Numbers: 09-022
100041 ( Other Identifier: Cook )
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: September 2013

Keywords provided by Cook Group Incorporated:
Colonic obstruction

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases