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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00991614
First received: August 13, 2009
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Duodenal Obstruction
Gastric Outlet Obstruction
 Device: EVOLUTION® Duodenal Stent

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Treatment of Duodenal or Gastric Outlet Obstruction and Duodenal Strictures Caused by Malignant Neoplasms With the EVOLUTION® Duodenal Stent

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Patency of the stent [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Procedural success, implant duration, symptom resolution [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: December 2009
Study Completion Date: March 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
EVOLUTION® Duodenal Stent Device: EVOLUTION® Duodenal Stent
EVOLUTION® Duodenal Stent
Other Name: TC325

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are referred into regional specialty centers for treatment of GI malignancy.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991614

Locations
Australia
Westmead Hospital
Sydney, Australia, 2145
Canada, Quebec
Hopital Saint-Luc / CHUM
Montreal, Quebec, Canada, H2X3J4
Czech Republic
Institution for Clinical and Experimental Medicine
Praha, Czech Republic
Italy
IRCCS Instituto Clinico Humanitas
Milan, Italy, 20089
U.O. Endoscopia Digestiva Chirurgica
Rome, Italy, 00168
Netherlands
Erasmus MC University Medical Center
Rotterdam, Netherlands, 3015 CE
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Professor Guido Costamagna, MD U.O. Endoscopia Digestiva Chirurgica
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00991614     History of Changes
Other Study ID Numbers: 09-005
Study First Received: August 13, 2009
Last Updated: March 28, 2012
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Neoplasms
Duodenal Obstruction
Gastric Outlet Obstruction
Pyloric Stenosis
Duodenal Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Obstruction
Stomach Diseases

ClinicalTrials.gov processed this record on May 16, 2013