SpyGlass™ Discover Percutaneous

Boston Scientific

Status: Completed

Conditions: Pancreatic Diseases; Bile Duct Diseases; Bile Duct Obstruction

Treatments: Device: SpyGlass™ Discover Digital System

Study type: Observational

Funder types: Industry

Identifiers

NCT04580940

E7160

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Subjects with complex pancreaticobiliary disease

Description:

All subjects will undergo the percutaneous transhepatic cholangiopancreatoscopy with the SpyGlass Discover System.

Treatment:

Device: SpyGlass™ Discover Digital System