Spy II Clinical Registry - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00751998

Purpose

A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.

Condition	Intervention	Phase
Biliary Tract Diseases	Device: SpyGlass	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Ability to visualize stricture and obtain biopsy adequate for histological examination if target lesion identified. [ Time Frame: Post Procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety profile [ Time Frame: Procedural and ongoing ] [ Designated as safety issue: Yes ]
Impact on diagnosis and patient management [ Time Frame: Procedural or at 12 months ] [ Designated as safety issue: No ]
Sensitivity and specificity of SpyBite biopsy for intraductal malignancy [ Time Frame: Procedural or at 12 months ] [ Designated as safety issue: No ]
Health Economics [ Time Frame: Procedural or at 12 months ] [ Designated as safety issue: No ]
Device durability [ Time Frame: Procedural or at 12 months ] [ Designated as safety issue: No ]

Enrollment:	297
Study Start Date:	November 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental Test of SpyGlass device	Device: SpyGlass The SpyGlass Direct Visualization System is an integrated product platform that is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices.

Eligibility

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

Criteria

Inclusion Criteria:

Male or female >= 18 years of age
Willing and able to comply with the Registry procedures and provide written informed consent to participate in the Registry
Indicated for ERCP or ERCP/cholangioscopy (with or without biopsy)

Exclusion Criteria:

Subjects for whom endoscopic procedure are medically contraindicated
Subjects for whom ERCP are medically contraindicated
Subjects for whom medical condition warrants use of device outside of indication for use

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751998

Locations

United States, California
California Pacific Medical Center
San Francisco, California, United States, 94120
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202-5253
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905-0001
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15123
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0001
Belgium
Erasme Hospital - Belgium
Brussels, Belgium, 1070
Denmark
Bispebjerg Hospital, Denmark
Kobenhavn NV, Denmark, 2400
France
Hopital Edouard Herriot
Lyon, Cedex 03, France, 69437
Germany
Evangelisches Krankenhaus Dusseldorf
Dusseldorf, Germany, D-40217
Italy
Policlinico Agostino Gemelli
Roma, Italy, 00161

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Study Director:

Joyce Peetermans, PhD

Boston Scientific Corporation

More Information

No publications provided

Responsible Party:	Boston Scientific ( Joy Peetermans, PhD )
Study ID Numbers:	E7012
Study First Received:	September 11, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00751998 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:

biliary
ERCP
cholangioscopy
pancreatic

Study placed in the following topic categories:

Digestive System Diseases
Biliary Tract Diseases

Additional relevant MeSH terms:

Digestive System Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on May 07, 2009