NCT04580940

SpyGlass™ Discover Percutaneous

Flexible Percutaneous Transhepatic Cholangiopancreatoscopy (PTCS) in Complex Pancreaticobiliary Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Pancreatic Diseases
• Bile Duct Obstruction
• Bile Duct Diseases

Interventions

Type	Name	Description
DEVICE	SpyGlass™ Discover Digital System	Observational, prospective, registry study for the clinical utility of the SpyGlass Discover digital catheter during a PTCS procedure.

Timeline

• Start date: 2021-07-27
• Primary completion: 2022-12-14
• Completion: 2023-01-14
• First posted: 2020-10-09
• Last updated: 2023-11-29

Locations

7 sites across 7 countries: United States, Belgium, Canada, Germany, Hong Kong, India, Italy

Regulatory

• FDA-regulated device study