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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00991614

Enrollment

110

Registered

2009-10-08

Start date

2009-12-31

Completion date

2012-03-31

Last updated

2012-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duodenal Obstruction, Gastric Outlet Obstruction

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.

Interventions

DEVICEEVOLUTION® Duodenal Stent

EVOLUTION® Duodenal Stent

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Patency of the stent	14 days

Secondary

Measure	Time frame
Procedural success, implant duration, symptom resolution	up to 6 months

Countries

Australia, Canada, Czechia, Italy, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026