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

Cook Group Incorporated110 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

110

Conditions

Duodenal Obstruction Gastric Outlet Obstruction

Interventions

EVOLUTION® Duodenal StentDEVICE

EVOLUTION® Duodenal Stent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Westmead Hospital

Sydney, Australia

Hopital Saint-Luc / CHUM

Montreal, Quebec, Canada

Institution for Clinical and Experimental Medicine

Prague, Czechia

IRCCS Instituto Clinico Humanitas

Milan, Italy

Outcomes

Primary Outcomes

Patency of the stent

Time frame: 14 days

Secondary Outcomes

Procedural success, implant duration, symptom resolution

Time frame: up to 6 months

Data from ClinicalTrials.gov

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