A Study of the WallFlex™ Biliary Fully-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

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-05-31

Brief Summary

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The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-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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Cholestasis, Extrahepatic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WallFlex Biliary Fully Covered stent

Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent

Group Type EXPERIMENTAL

WallFlex™ Biliary Fully Covered Metal Stent placement

Intervention Type DEVICE

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

Interventions

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WallFlex™ Biliary Fully Covered Metal Stent placement

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18 or older
* Clinical symptoms of biliary obstruction
* Inoperable extrahepatic biliary obstruction by any malignant process
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria

* Participation in an Investigational Study within 90 days prior to date of patient consent
* Strictures that cannot be dilated enough to pass the delivery system
* Perforation of any duct within the biliary tree
* Presence of a metal biliary stent
* Presence of any esophageal or duodenal stent
* Patients for whom endoscopic procedures are contraindicated
* Patients with known sensitivity to any components of the stent or delivery system
* Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
* Patients with an anticipated life expectancy of \< 3 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No