Spy II Clinical Registry - Full Text View

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 or at 12 months ] [ Designated as safety issue: Yes ]
Impact on diagnosis and patient management [ Time Frame: Procedural or at 12 months ] [ Designated as safety issue: Yes ]
Sensitivity and specificity of SpyBite biopsy for intraductal malignancy [ Time Frame: Procedural or at 12 months ] [ Designated as safety issue: Yes ]
Health Economics [ Time Frame: Procedural or at 12 months ] [ Designated as safety issue: Yes ]
Device durability [ Time Frame: Procedural or at 12 months ] [ Designated as safety issue: Yes ]

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

Responsible Party:	Boston Scientific ( Jessica Musiak )
Study ID Numbers:	E7012
First Received:	September 11, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00751998
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

ClinicalTrials.gov processed this record on October 03, 2008

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