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

Completed

• Conditions: Duodenal Obstruction; Gastric Outlet Obstruction

• Registration Number: NCT00991614
• Lead Sponsor: Cook Group Incorporated

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 Description

Not available

Study Timeline

• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-10-07
• Study First Posted: 2009-10-08
• Study Start: 2009-12
• Primary Completion: 2011-06
• Status Verified: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Patients for whom this device would be chosen in standard practice

Exclusion Criteria

• Patients for whom this device would not normally be chosen in standard practice

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patency of the stent	14 days

Secondary Outcome Measures

Name	Time	Method
Procedural success, implant duration, symptom resolution	up to 6 months

Trial Locations

Locations (6)

Westmead Hospital; 🇦🇺 Sydney, Australia

Hopital Saint-Luc / CHUM; 🇨🇦 Montreal, Quebec, Canada

Institution for Clinical and Experimental Medicine; 🇨🇿 Praha, Czech Republic

IRCCS Instituto Clinico Humanitas; 🇮🇹 Milan, Italy

U.O. Endoscopia Digestiva Chirurgica; 🇮🇹 Rome, Italy

Erasmus MC University Medical Center; 🇳🇱 Rotterdam, Netherlands