SpyGlass Surgical Study

Boston Scientific

Status: Completed

Conditions: Pancreatic Diseases; Bile Duct Diseases; Hepatic Disease

Treatments: Device: SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System

Study type: Observational

Funder types: Industry

Identifiers

NCT05822635

E7161

Details and patient eligibility

About

• 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

Full 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

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical indication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
• Written informed consent from patient or legally authorized representative of the patient

Exclusion criteria

• Contraindication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
• <18 years of age
• Potentially vulnerable subjects, including, but not limited to pregnant women

Trial design

34 participants in 1 patient group

Subjects with complex pancreaticobiliary disease

Description:

All subjects will undergo the intraoperative endoscopy with either the SpyGlass Discover System or the SpyGlass DS Direct Visualization System.

Treatment:

Device: SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System