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
1 other identifier
observational
110
5 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2009
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2009
CompletedFirst Posted
Study publicly available on registry
October 8, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMarch 29, 2012
March 1, 2012
1.5 years
August 13, 2009
March 28, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Patency of the stent
14 days
Secondary Outcomes (1)
Procedural success, implant duration, symptom resolution
up to 6 months
Study Arms (1)
EVOLUTION® Duodenal Stent
Interventions
EVOLUTION® Duodenal Stent
Eligibility Criteria
Patients who are referred into regional specialty centers for treatment of GI malignancy.
You may qualify if:
- Patients for whom this device would be chosen in standard practice
You may not qualify if:
- Patients for whom this device would not normally be chosen in standard practice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Westmead Hospital
Sydney, 2145, Australia
Hopital Saint-Luc / CHUM
Montreal, Quebec, H2X3J4, Canada
Institution for Clinical and Experimental Medicine
Prague, Czechia
IRCCS Instituto Clinico Humanitas
Milan, 20089, Italy
U.O. Endoscopia Digestiva Chirurgica
Rome, 00168, Italy
Erasmus MC University Medical Center
Rotterdam, 3015 CE, Netherlands
Related Publications (1)
Tringali A, Didden P, Repici A, Spaander M, Bourke MJ, Williams SJ, Spicak J, Drastich P, Mutignani M, Perri V, Roy A, Johnston K, Costamagna G. Endoscopic treatment of malignant gastric and duodenal strictures: a prospective, multicenter study. Gastrointest Endosc. 2014 Jan;79(1):66-75. doi: 10.1016/j.gie.2013.06.032. Epub 2013 Aug 6.
PMID: 23932009DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Professor Guido Costamagna, MD
U.O. Endoscopia Digestiva Chirurgica
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2009
First Posted
October 8, 2009
Study Start
December 1, 2009
Primary Completion
June 1, 2011
Study Completion
March 1, 2012
Last Updated
March 29, 2012
Record last verified: 2012-03