SpyGlass™ Discover Percutaneous

Boston Scientific Corporation50 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pancreatic Diseases Bile Duct Obstruction Bile Duct Diseases

Interventions

SpyGlass™ Discover Digital SystemDEVICE

Observational, prospective, registry study for the clinical utility of the SpyGlass Discover digital catheter during a PTCS procedure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. Written informed consent from patient or legally authorized representative of the patient Exclusion Criteria: 1. Contraindication for cholangiopancreatoscopy 2. Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access 3. \<18 years of age 4. Potentially vulnerable subjects, including, but not limited to pregnant women

Locations (7)

Virginia Mason Medical Center

Seattle, Washington, United States

Erasme University Hospital

Brussels, Belgium

Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Evangelisches Krakenhaus Düsseldorf

Düsseldorf, Germany

Outcomes

Primary Outcomes

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.

Time frame: 1 month

Secondary Outcomes

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).

Time frame: 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

Time frame: During index procedure

Procedural Time

Time elapsed between first insertion to last removal of the SpyGlass™ Discover digital catheter

Time frame: During index procedure

Number of PTCS procedures

Number of PTCS procedures required to achieve clinical success until the end of follow-up

Time frame: 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

Time frame: During index procedure

Data from ClinicalTrials.gov

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