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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

September 11, 2008
February 4, 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 ] [ Designated as safety issue: No ]
Ability to visualize stricture and obtain biopsy adequate for histological examination if target lesion identified. [ Time Frame: Post Procedure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00751998 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
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
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
297
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Denmark,   France,   Germany,   Italy
 
NCT00751998
E7012
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