SpyGlass Surgical Study

Study Overview
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Brief Summary
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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
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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

Official Title
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Intraoperative Endoscopy Using a Thin, Single-Use, Flexible Cholangiopancreatoscope

Conditions
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Pancreatic Diseases, Bile Duct Diseases, Hepatic Disease

Intervention / Treatment
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* Device: SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with complex pancreaticobiliary disease<br>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<br>* Observational, prospective study for the clinical utility of the SpyGlass Discover Digital Catheter and the SpyScope DS Catheter during an intraoperative endoscopy procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | During study procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | During study procedure | 
| Adequate diagnostic yield | Adequate diagnostic yield of tissue biopsy for histopathology assessment | 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: Image quality Ability to irrigate field of view through the irrigation channels Ability to aspirate through the working channel Ability to retroflex Ability to obtain targeted biopsies using biopsy forceps Ability to grasp stones using wire basket Ability to perform lithotripsy Ability to advance accessories through catheter Ability to selectively advance into targeted ducts | During study procedure |