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

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00713427
First received: July 9, 2008
Last updated: August 31, 2009
Last verified: August 2009
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
ULB Erasme Hospital
Brussels, Belgium, 1070
France
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
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: Jeremy Bolt, Boston Scientific
ClinicalTrials.gov Identifier: NCT00713427     History of Changes
Other Study ID Numbers: ENDO-WALLFLEX-BIL-PALL-002, E7020
Study First Received: July 9, 2008
Last Updated: August 31, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Boston Scientific Corporation:
Biliary
Strictures
Malignant
Neoplasm
Palliation

Additional relevant MeSH terms:
Neoplasms
Cholestasis
Constriction, Pathologic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 23, 2014