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OpenTrials
Completed

NCT Number: NCT01102283

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kingston General Hospital, Kingston, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evolution(R) Colonic Stent

Device

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 outcomes

  1. Relief of obstruction

    Time frame: At the Conclusion of the Procedure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Apr 13, 2010
Registry last updated
Sep 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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