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Spy II Clinical Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00751998
First received: September 11, 2008
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:
  • Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal. [ Time Frame: During Procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Diagnosis. [ Time Frame: Procedural through end of study ] [ Designated as safety issue: No ]
  • Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Subject Management. [ Time Frame: Procedure or at 12 months ] [ Designated as safety issue: No ]
  • Ability to Visualize and Access Various Targeted Anatomic Areas. [ Time Frame: Procedure ] [ Designated as safety issue: No ]
  • Sensitivity of SpyBite Biopsy Forceps in Malignant Strictures. [ Time Frame: Post Procedure ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Procedural through end of study ] [ Designated as safety issue: Yes ]
  • Device Durability and Device Performance. [ Time Frame: Procedure ] [ Designated as safety issue: No ]
  • Health Resources Utilization (Health Economics) [ Time Frame: Procedure through end of study. ] [ Designated as safety issue: No ]

Enrollment: 297
Study Start Date: November 2006
Study Completion Date: October 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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 Corporation
ClinicalTrials.gov Identifier: NCT00751998     History of Changes
Other Study ID Numbers: E7012
Study First Received: September 11, 2008
Results First Received: March 16, 2011
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
biliary
ERCP
cholangioscopy
pancreatic

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013