Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

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: Large Bowel Obstruction; Colonic Obstruction; Colonic Stricture
• Intervention / Treatment: Device: Evolution(R) Colonic Stent

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

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

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

How is the study designed?

Number of groups / cohorts

1

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	At the Conclusion of the Procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cook Group Incorporated

Study record dates

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: Colonic obstruction
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: 09-022; 100041 (Cook)