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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00991614
Recruitment Status : Completed
First Posted : October 8, 2009
Last Update Posted : March 29, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Duodenal Obstruction Gastric Outlet Obstruction Device: EVOLUTION® Duodenal Stent

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Study Type : Observational
Actual Enrollment : 110 participants
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
Study Start Date : December 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : March 2012

Group/Cohort Intervention/treatment
EVOLUTION® Duodenal Stent Device: EVOLUTION® Duodenal Stent
EVOLUTION® Duodenal Stent
Other Name: TC325

Primary Outcome Measures :
  1. Patency of the stent [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Procedural success, implant duration, symptom resolution [ Time Frame: up to 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are referred into regional specialty centers for treatment of GI malignancy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00991614

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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
IRCCS Instituto Clinico Humanitas
Milan, Italy, 20089
U.O. Endoscopia Digestiva Chirurgica
Rome, Italy, 00168
Erasmus MC University Medical Center
Rotterdam, Netherlands, 3015 CE
Sponsors and Collaborators
Cook Group Incorporated
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Principal Investigator: Professor Guido Costamagna, MD U.O. Endoscopia Digestiva Chirurgica
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Cook Group Incorporated Identifier: NCT00991614    
Other Study ID Numbers: 09-005
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Gastric Outlet Obstruction
Pyloric Stenosis
Duodenal Obstruction
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Duodenal Diseases
Intestinal Diseases
Intestinal Obstruction