Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
34 participants
OBSERVATIONAL
2023-12-01
2025-01-03
Brief Summary
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* 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
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Detailed Description
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* 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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects with complex pancreaticobiliary disease
All subjects will undergo the intraoperative endoscopy with either the SpyGlass Discover System or the SpyGlass DS Direct Visualization System.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent from patient or legally authorized representative of the patient
Exclusion Criteria
* \<18 years of age
* Potentially vulnerable subjects, including, but not limited to pregnant women
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Locations
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Indiana University Health
Indianapolis, Indiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Lanzhou University No. 1 Hospital
Lanzhou, Gansu, China
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Asian Institute of Gastroenterology
Hyderabad, Telangana, India
Countries
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Other Identifiers
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E7161
Identifier Type: -
Identifier Source: org_study_id
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