Intraoperative Endoscopy Using a Thin, Single-Use, Flexible Cholangiopancreatoscope
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Diseases
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 34
- Locations
- 5
- Primary Endpoint
- Technical success
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Technical success
Time Frame: During study procedure
Perform intraoperative endoscopy as intended using a thin, single-use, flexible cholangiopancreatoscope as desired, including but not limited to: * Direct visualization of target lesion or stricture * Obtaining biopsies * Initiating and/or completing stone clearance
Secondary Outcomes
- Number of adverse events(1 month)
- Endoscopist rating of clinical impact of study procedure(During study procedure)
- Endoscopist rating of device(During study procedure)
- Adequate diagnostic yield(1 month)