NCT02287194

SpyGlass Direct Visualization System Clinical Registry in China

Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System Throughout China

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 197 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Biliary Tract Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-11-28
• Primary completion: 2016-04-30
• Completion: 2017-12-31
• First posted: 2014-11-10
• Last updated: 2018-07-31

Locations

1 site across 1 country: China