Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

September 16, 2013 updated by: Cook Group Incorporated
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Referral Centers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relief of obstruction
Time Frame: At the Conclusion of the Procedure
At the Conclusion of the Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Duration
Time Frame: 6 months
6 months
Symptoms at Follow-up
Time Frame: 6 months
6 months
Complications
Time Frame: 6 months
perforation, migration, obstruction, GI bleeding requiring intervention
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Estimate)

September 18, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-022
  • 100041 (Cook)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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