An observational study in Pancreatic Diseases, Bile Duct Diseases and Hepatic Disease, sponsored by Boston Scientific Corporation. Completed at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by Boston Scientific Corporation · Observational
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:
169 studies on the registry are indexed under Pancreatic Diseases; 62 are open to participants now.
This study's enrollment of 34 is below the median of 330 across 81 observational studies indexed under Pancreatic Diseases.
Browse Pancreatic Diseases studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
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Patients with complex pancreaticobiliary disease
Exclusion Criteria:
All subjects will undergo the intraoperative endoscopy with either the SpyGlass Discover System or the SpyGlass DS Direct Visualization System.
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.
Technical success
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
Time frame: During study procedure
Number of adverse events
Serious adverse events related to the study device, accessory devices used throughout the working channel of the SpyGlass™ system, or the intraoperative endoscopy procedure
Time frame: 1 month
Endoscopist rating of clinical impact of study procedure
Characterization and rating of the clinical benefit and impact of intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope to the surgical procedure on a 1 (highly dissatisfied) to 10 (highly satisfied) scale
Time frame: During study procedure
Adequate diagnostic yield
Adequate diagnostic yield of tissue biopsy for histopathology assessment
Time frame: 1 month
Endoscopist rating of device
Rating of the intraoperative performance of the SpyGlass™ system and accessories during intraoperative endoscopy procedure compared to marketed reusable endoscopes on a 1 (highly dissatisfied) to 10 (highly satisfied) scale: 1. Image quality 2. Ability to irrigate field of view through the irrigation channels 3. Ability to aspirate through the working channel 4. Ability to retroflex 5. Ability to obtain targeted biopsies using biopsy forceps 6. Ability to grasp stones using wire basket 7. Ability to perform lithotripsy 8. Ability to advance accessories through catheter 9. Ability to selectively advance into targeted ducts
Time frame: During study procedure
Plan to share: No
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Boston Scientific Corporation