NCT00991614

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Cook Group Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Duodenal Obstruction
• Gastric Outlet Obstruction

Interventions

Type	Name	Description
DEVICE	EVOLUTION® Duodenal Stent	EVOLUTION® Duodenal Stent

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-06-01
• Completion: 2012-03-01
• First posted: 2009-10-08
• Last updated: 2012-03-29

Locations

6 sites across 5 countries: Australia, Canada, Czechia, Italy, Netherlands