Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
This study has been completed.
Sponsor:
Boston Scientific Corporation
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00713427
First received: July 9, 2008
Last updated: August 31, 2009
Last verified: August 2009
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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
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 May 16, 2013