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

Sponsor
Cook Group Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00991614
Collaborator
(none)
110
Enrollment
6
Locations
27
Duration (Months)
18.3
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: EVOLUTION® Duodenal Stent

Study Design

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 :
Dec 1, 2009
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
EVOLUTION® Duodenal Stent

Device: EVOLUTION® Duodenal Stent
EVOLUTION® Duodenal Stent
Other Names:
  • TC325

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Patency of the stent [14 days]

    Secondary Outcome Measures

    1. Procedural success, implant duration, symptom resolution [up to 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Westmead Hospital Sydney Australia 2145
    2 Hopital Saint-Luc / CHUM Montreal Quebec Canada H2X3J4
    3 Institution for Clinical and Experimental Medicine Praha Czech Republic
    4 IRCCS Instituto Clinico Humanitas Milan Italy 20089
    5 U.O. Endoscopia Digestiva Chirurgica Rome Italy 00168
    6 Erasmus MC University Medical Center Rotterdam Netherlands 3015 CE

    Sponsors and Collaborators

    • Cook Group Incorporated

    Investigators

    • Principal Investigator: Professor Guido Costamagna, MD, U.O. Endoscopia Digestiva Chirurgica

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cook Group Incorporated
    ClinicalTrials.gov Identifier:
    NCT00991614
    Other Study ID Numbers:
    • 09-005
    First Posted:
    Oct 8, 2009
    Last Update Posted:
    Mar 29, 2012
    Last Verified:
    Mar 1, 2012
    Additional relevant MeSH terms:
    Neoplasms
    Gastric Outlet Obstruction
    Pyloric Stenosis
    Duodenal Obstruction

    Study Results

    No Results Posted as of Mar 29, 2012