SpyGlass™ Discover Percutaneous

Flexible Percutaneous Transhepatic Cholangiopancreatoscopy (PTCS) in Complex Pancreaticobiliary Disease

To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series

This case series aims to illustrate the clinical utility of percutaneous transhepatic cholangiopancreatoscopy using a thin, disposable, flexible endoscope performed by gastroenterological endoscopists and/or interventional radiologists in procedures including but not limited to:

• PTCS for tissue diagnosis in cases of surgically or pathologically-altered anatomy,
• PTCS for stone removal after surgically or pathologically-altered anatomy,
• Percutaneous rendezvous to aid ERCP after failed endoscopic cannulation,
• Percutaneous delivery of palliative intraluminal brachytherapy,
• Intra-procedural percutaneous salvage procedures when an initial route of access fails

Inclusion Criteria:

1. Scheduled for a percutaneous transhepatic procedure to access the pancreaticobiliary anatomy that will accommodate passage of SpyGlass™ Discover Digital Catheter per local standard of practice
2. Written informed consent from patient or legally authorized representative of the patient

Exclusion Criteria:

1. Contraindication for cholangiopancreatoscopy
2. Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access
3. <18 years of age
4. Potentially vulnerable subjects, including, but not limited to pregnant women