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

March 28, 2012 updated by: Cook Group Incorporated

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Sydney, Australia, 2145
        • Westmead Hospital
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X3J4
        • Hopital Saint-Luc / CHUM
  • Czech Republic
      • Praha, Czech Republic
        • Institution for Clinical and Experimental Medicine
  • Italy
      • Milan, Italy, 20089
        • IRCCS Instituto Clinico Humanitas
      • Rome, Italy, 00168
        • U.O. Endoscopia Digestiva Chirurgica
  • Netherlands
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus MC University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EVOLUTION® Duodenal Stent
Device: EVOLUTION® Duodenal Stent
EVOLUTION® Duodenal Stent
Other Names:
  • TC325

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patency of the stent
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedural success, implant duration, symptom resolution
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

October 7, 2009

First Posted (Estimate)

October 8, 2009

Study Record Updates

Last Update Posted (Estimate)

March 29, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-005 (Other Identifier: Massachusetts General Hospital Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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