Clinical Trial: Spy II Clinical Registry
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System
Brief Summary: A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.
Detailed Summary:
Sponsor: Boston Scientific Corporation
Current Primary Outcome: 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 ]
Original Primary Outcome: Ability to visualize stricture and obtain biopsy adequate for histological examination if target lesion identified. [ Time Frame: Post Procedure ]
Current Secondary Outcome:
- 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. ]
Original Secondary Outcome:
- 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 ]
Information By: Boston Scientific Corporation
Dates:
Date Received: September 11, 2008
Date Started: November 2006
Date Completion:
Last Updated: February 4, 2013
Last Verified: February 2013