Study of the WallFlex™ Biliary Partially-Covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00713427

Purpose

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.

Condition	Intervention
Biliary Strictures Caused by Malignant Neoplasms	Device: WallFlex™ Biliary Partially-Covered Stent

MedlinePlus related topics: Cancer Palliative Care

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-Covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

The primary outcome measured will be the adequate clinical palliation of the biliary obstruction defined as absence of recurrent biliary obstruction. Recurrent biliary obstruction will be determined by treating physicians. [ Time Frame: 6 months or death, whichever comes first ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary outcome measures include the occurrence, severity, device- and procedure-relatedness of adverse events, device deployability and removability, re-interventions, biliary obstruction symptoms, liver function, and recurrent biliary obstruction. [ Time Frame: 6 months or death, whichever comes first ] [ Designated as safety issue: Yes ]

Enrollment:	70
Study Start Date:	July 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Device: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713427

Locations

Belgium
ULB Erasme Hospital
Brussels, Belgium, 1070
France, Cedex 3
Hopital Edouard Herriot
Lyon, Cedex 3, France, 69437
Germany
EVK Krankenhaus der Universitat Dusseldorf
Dusseldorf, Germany, D-40217
India
Asian Institute of Gastroenterology
Hyderabaad, India, 500082
Italy
Università Cattolica del Sacro Cuore
Rome, Italy, 00168
Netherlands, AZ
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, AZ, Netherlands, 1105

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Study Director:	Robert Walsh, M.D.	Boston Scientific Corporation
Principal Investigator:	Guido Costamagna, M.D.	Università Cattolica del Sacro Cuore, Policlinico A. Gemelli

More Information

No publications provided

Responsible Party:	Boston Scientific ( Jeremy Bolt )
Study ID Numbers:	ENDO-WALLFLEX-BIL-PALL-002, E7020
Study First Received:	July 9, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00713427 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Boston Scientific Corporation:

Biliary
Strictures
Malignant
Neoplasm
Palliation

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Digestive System Diseases
Bile Duct Diseases

Cholestasis
Biliary Tract Diseases
Constriction, Pathologic

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Neoplasms
Digestive System Diseases
Bile Duct Diseases

Cholestasis
Biliary Tract Diseases
Constriction, Pathologic

ClinicalTrials.gov processed this record on May 07, 2009