NCT05822635

SpyGlass Surgical Study

Intraoperative Endoscopy Using a Thin, Single-Use, Flexible Cholangiopancreatoscope

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope * To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and generate a hypothesis for possible subsequent claims-supportive study

Detailed description

This case series aims to document the clinical utility of intraoperative endoscopy using a thin, disposable, flexible cholangiopancreatoscope in procedures including but not limited to: * Evaluation of biliary lesion(s) during surgical management of common bile duct (CBD) and intrahepatic duct (IHD) strictures, with or without biopsy * Transcystic/transcholedochal clearance of biliary stone(s)/sludge/cast with or without mechanical, electrohydraulic or laser lithotripsy * Treatment of hepatolithiasis * Assessment of communication between the biliary tree and the cyst in the setting of ruptured hydatid parasitic cysts or abcesses * Visualization of intraductal papillary mucinous neoplasm (IPMN) lesion(s) with or without biopsy * Assessment of pancreatic duct (PD) strictures in chronic pancreatitis, with or without biopsy

Conditions

• Pancreatic Diseases
• Bile Duct Diseases
• Hepatic Disease

Interventions

Type	Name	Description
DEVICE	SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System	Observational, prospective study for the clinical utility of the SpyGlass Discover Digital Catheter and the SpyScope DS Catheter during an intraoperative endoscopy procedure.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-04
• Completion: 2025-01-03
• First posted: 2023-04-21
• Last updated: 2025-01-08

Locations

5 sites across 4 countries: United States, China, Hong Kong, India

Regulatory

• FDA-regulated device study