Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-05-31

Brief Summary

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This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.

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Detailed Description

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Conditions

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Biliary Strictures Caused by Malignant Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WallFlex Stent

All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.

Group Type OTHER

WallFlex™ Biliary Partially-Covered Stent

Intervention Type DEVICE

Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.

Interventions

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WallFlex™ Biliary Partially-Covered Stent

Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older
* Inoperable extrahepatic biliary obstruction by any malignant process
* Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion Criteria

* Participation in another invesitgational study within 90 days prior to date of patient consent.
* Strictures that cannot be dialated enough to pass the delivery system
* Perforation of any duct within the biliary tree
* Presence of any esophageal or duodenal stent
* Patients for whom endoscopic procedures are contraindicated
* Patients with known senesitivity to any components of the stent or delivery system
* Patients with active hepatitis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No