SpyGlass™ Discover Percutaneous

Study Overview
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Brief Summary
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To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series

Detailed Description
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This case series aims to illustrate the clinical utility of percutaneous transhepatic cholangiopancreatoscopy using a thin, disposable, flexible endoscope performed by gastroenterological endoscopists and/or interventional radiologists in procedures including but not limited to: PTCS for tissue diagnosis in cases of surgically or pathologically-altered anatomy, PTCS for stone removal after surgically or pathologically-altered anatomy, Percutaneous rendezvous to aid ERCP after failed endoscopic cannulation, Percutaneous delivery of palliative intraluminal brachytherapy, Intra-procedural percutaneous salvage procedures when an initial route of access fails

Official Title
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Flexible Percutaneous Transhepatic Cholangiopancreatoscopy (PTCS) in Complex Pancreaticobiliary Disease

Conditions
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Pancreatic Diseases, Bile Duct Obstruction, Bile Duct Diseases

Intervention / Treatment
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* Device: SpyGlass™ Discover Digital System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for a percutaneous transhepatic procedure to access the pancreaticobiliary anatomy that will accommodate passage of SpyGlass™ Discover Digital Catheter per local standard of practice Written informed consent from patient or legally authorized representative of the patient Exclusion Criteria: Contraindication for cholangiopancreatoscopy Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access <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 percutaneous transhepatic cholangiopancreatoscopy with the SpyGlass Discover System. | Device: SpyGlass™ Discover Digital System<br>* Observational, prospective, registry study for the clinical utility of the SpyGlass Discover digital catheter during a PTCS procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving clinical intent of procedure as indicated | Physicians will report achieving clinical success by recording the completed procedures compared to procedures planned by 30 days (+/- 3 days) after index PTCS. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | Serious adverse events related to the study device, accessory devices used through the working channel of the SpyGlass™ Discover Digital Catheter or the cholangiopancreatoscopy portion of the PTCS procedure(s). | 1 month | 
| Technical success | Rate at which SpyGlass™ Discover digital catheter can be advanced to the target lesion or stone(s) and visualize the target | During index procedure | 
| Procedural Time | Time elapsed between first insertion to last removal of the SpyGlass™ Discover digital catheter | During index procedure | 
| Number of PTCS procedures | Number of PTCS procedures required to achieve clinical success until the end of follow-up | 1 month | 
| Endoscopist rating | Endoscopist rating of the following attributes when using SpyGlass™ Discover Digital Catheter compared to marketed reusable scopes Ability to complete the procedure Ability to retroflex Ability to selectively advance into targeted ducts Ability to obtain targeted biopsies Ability to grasp stones Ability to guide lithotripsy Ability to suction Ability to irrigate Ability to advance accessories through scope channel Image quality | During index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous transhepatic cholangiopancreatoscopy, spyglass discover, pancreaticobiliary disease