SpyGlass™ Discover Percutaneous

Completed

• Conditions: Bile Duct Obstruction; Pancreatic Diseases; Bile Duct Diseases
• Interventions: Device: SpyGlass™ Discover Digital System

• Registration Number: NCT04580940
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-09
• Study Start: 2021-07-27
• Primary Completion: 2022-12-14
• Study Completion: 2023-01-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with complex pancreaticobiliary disease	SpyGlass™ Discover Digital System	All subjects will undergo the percutaneous transhepatic cholangiopancreatoscopy with the SpyGlass Discover System.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events	1 month	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).
Technical success	During index procedure	Rate at which SpyGlass™ Discover digital catheter can be advanced to the target lesion or stone(s) and visualize the target
Procedural Time	During index procedure	Time elapsed between first insertion to last removal of the SpyGlass™ Discover digital catheter
Endoscopist rating	During index procedure	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
Number of PTCS procedures	1 month	Number of PTCS procedures required to achieve clinical success until the end of follow-up

Trial Locations

Locations (7)

Toronto General Hospital, University Health Network; 🇨🇦 Toronto, Ontario, Canada

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

Erasme University Hospital; 🇧🇪 Brussels, Belgium

Evangelisches Krakenhaus Düsseldorf; 🇩🇪 Düsseldorf, Germany

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, Somajiguda, India

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy

Prince of Wales Hospital; 🇭🇰 Shatin, NewTerritories, Hong Kong