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

Gastric Outlet Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991614
• Other study ID #: 09-005
• Status: Completed
• Phase: N/A
• First received: August 13, 2009
• Last updated: March 28, 2012
• Start date: December 2009
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Duodenal Obstruction
• Gastric Outlet Obstruction
• Neoplasms
• Pyloric Stenosis

Intervention

Device:
• EVOLUTION® Duodenal Stent
EVOLUTION® Duodenal Stent

Locations

Country	Name	City	State
Australia	Westmead Hospital	Sydney
Canada	Hopital Saint-Luc / CHUM	Montreal	Quebec
Czech Republic	Institution for Clinical and Experimental Medicine	Praha
Italy	IRCCS Instituto Clinico Humanitas	Milan
Italy	U.O. Endoscopia Digestiva Chirurgica	Rome
Netherlands	Erasmus MC University Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Countries where clinical trial is conducted

Australia,  Canada,  Czech Republic,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency of the stent		14 days	Yes
Secondary	Procedural success, implant duration, symptom resolution		up to 6 months	Yes