Spy II Clinical Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00751998
Recruitment Status : Completed
First Posted : September 12, 2008
Results First Posted : April 12, 2011
Last Update Posted : February 11, 2013
Information provided by (Responsible Party):
Boston Scientific Corporation

September 11, 2008
September 12, 2008
March 16, 2011
April 12, 2011
February 11, 2013
November 2006
April 2008   (Final data collection date for primary outcome measure)
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 ]
Ability to visualize stricture and obtain biopsy adequate for histological examination if target lesion identified. [ Time Frame: Post Procedure ]
Complete list of historical versions of study NCT00751998 on Archive Site
  • Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Diagnosis. [ Time Frame: Procedural through end of study ]
  • Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Subject Management. [ Time Frame: Procedure or at 12 months ]
  • Ability to Visualize and Access Various Targeted Anatomic Areas. [ Time Frame: Procedure ]
  • Sensitivity of SpyBite Biopsy Forceps in Malignant Strictures. [ Time Frame: Post Procedure ]
  • Safety [ Time Frame: Procedural through end of study ]
  • Device Durability and Device Performance. [ Time Frame: Procedure ]
  • Health Resources Utilization (Health Economics) [ Time Frame: Procedure through end of study. ]
  • Safety profile [ Time Frame: Procedural or at 12 months ]
  • Impact on diagnosis and patient management [ Time Frame: Procedural or at 12 months ]
  • Sensitivity and specificity of SpyBite biopsy for intraductal malignancy [ Time Frame: Procedural or at 12 months ]
  • Health Economics [ Time Frame: Procedural or at 12 months ]
  • Device durability [ Time Frame: Procedural or at 12 months ]
Not Provided
Not Provided
Spy II Clinical Registry
A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System
A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Biliary Tract Diseases
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.
Experimental: Arm 1
Test of SpyGlass device
Intervention: Device: SpyGlass
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2009
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Denmark,   France,   Germany,   Italy,   United States
Not Provided
Not Provided
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Study Director: Joyce Peetermans, PhD Boston Scientific Corporation
Boston Scientific Corporation
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP