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Clinical Trial 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


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05822635
Study type Observational
Source Boston Scientific Corporation
Contact Bridget Stanford
Phone 7813151829
Email bridget.stanford@bsci.com
Status Recruiting
Phase
Start date December 1, 2023
Completion date May 2025

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