Clinical Trial: SpyGlass Direct Visualization System Clinical Registry in China
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational [Patient Registry]
Official Title: Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System Throughout China
Brief Summary:
To document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System in China when used per standard of practice.
Prospective, Post market, Multi-center, Non-randomized Study
Detailed Summary: Patients who presenting with an indication for cholangioscopy or presenting with a possible indication for cholangioscopy to be determined during the ERCP procedure immediately preceding the SpyGlass procedure will join this study, totally 500 patients across 16 sites throughout China will participate in study. After SpyGlass operation, all patients will be followed for 72 hours to observe adverse events, and patients with indeterminate stricture or undefined filling defect indication with tissue sampling not yielding histopathology positive for malignancy and unresolved device and/or procedure related SAE at 72 Hours will continue to be followed up until 6 months. Finally, procedure success rate will be analyzed as primary endpoint, and SAEs and impact of patients management will be analyzed as secondary endpoint.
Sponsor: Boston Scientific Corporation
Current Primary Outcome: Procedural success rate [ Time Frame: 72 hours ]
- For indeterminate strictures or undefined filling defects cases procedural success is defined as 1) ability to visualize stricture or defect, and 2) ability to provide visual impression of malignancy, and 3) when applicable, ability to obtain SpyBite biopsy adequate for histology
- For biliary stone cases procedural success is defined as 1) ability to visualize the stone(s), and 2) ability to successfully initiate stone fragmentation, and 3) ability to achieve stone clearance in one or more SpyGlass procedures.
- For other indications procedural success is defined as ability to establish diagnosis and /or complete therapy in the following categories: 1) pre-operative assessment of extent of peri-ampullary and biliary tumors, 2) selective guidewire placement, 3) assessment of unexplained hemobilia, 4) assessment of portal biliopathy, 5) assessment of intraductal biliary ablation therapy, 6) extraction of migrated stents, or 7) other.
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety Endpoints [ Time Frame: Post Procedure ]
Original Secondary Outcome: Same as current
Information By: Boston Scientific Corporation
Dates:
Date Received: August 20, 2014
Date Started: November 28, 2014
Date Completion: June 2017
Last Updated: March 7, 2017
Last Verified: March 2017
