Clinical Trial: EVOLUTION® Duodenal Stent for Duodenal or Gastric Outlet Obstruction Caused by Malignant Neoplasms

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Treatment of Duodenal or Gastric Outlet Obstruction and Duodenal Strictures Caused by Malignant Neoplasms With the EVOLUTION® Duodenal Stent

Brief Summary: The objective of this investigation is to compile clinical experience on the use of the Evolution® Duodenal Stent (Cook Ireland), a CE marked device intended for the palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms. It is not the goal to change the usual treatment practice of the investigator or the center, nor to collect information on uses outside the product's indications. Patients will be treated as per usual medical practices.

Detailed Summary:
Sponsor: Cook

Current Primary Outcome: Patency of the stent [ Time Frame: 14 days ]

Original Primary Outcome: Patency [ Time Frame: 14 days ]

Current Secondary Outcome: Procedural success, implant duration, symptom resolution [ Time Frame: up to 6 months ]

Original Secondary Outcome: Same as current

Information By: Cook

Dates:
Date Received: August 13, 2009
Date Started: December 2009
Date Completion:
Last Updated: March 28, 2012
Last Verified: March 2012