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

Overview

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.

Full Title of Study: “Treatment of Duodenal or Gastric Outlet Obstruction and Duodenal Strictures Caused by Malignant Neoplasms With the EVOLUTION® Duodenal Stent”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2011

Interventions

  • Device: EVOLUTION® Duodenal Stent
    • EVOLUTION® Duodenal Stent

Arms, Groups and Cohorts

  • EVOLUTION® Duodenal Stent

Clinical Trial Outcome Measures

Primary Measures

  • Patency of the stent
    • Time Frame: 14 days

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cook Group Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Professor Guido Costamagna, MD, Principal Investigator, U.O. Endoscopia Digestiva Chirurgica

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