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

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.

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Key information

Conditions

Duodenal Obstruction Digestive System Diseases Duodenal Diseases Gastric Outlet Obstruction Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Hospital, Sydney, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVOLUTION® Duodenal Stent

Device

EVOLUTION® Duodenal Stent

Other names: TC325

Primary outcomes

Patency of the stent

Time frame: 14 days

Secondary outcomes

Procedural success, implant duration, symptom resolution

Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2012
First posted: Oct 8, 2009
Registry last updated: Mar 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed