Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01102283
First received: March 29, 2010
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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 Intervention
Colonic Obstruction
Colonic Stricture
Large Bowel Obstruction
Device: Evolution(R) Colonic Stent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Relief of obstruction [ Time Frame: At the Conclusion of the Procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Implant Duration [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Symptoms at Follow-up [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    perforation, migration, obstruction, GI bleeding requiring intervention


Enrollment: 80
Study Start Date: April 2010
Study Completion Date: February 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01102283     History of Changes
Other Study ID Numbers: 09-022, 100041
Study First Received: March 29, 2010
Last Updated: September 16, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Cook:
Colonic obstruction

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

ClinicalTrials.gov processed this record on October 20, 2014