SpyGlass™ Discover Percutaneous

Pancreatic Diseases Clinical Trial

Official title:

Flexible Percutaneous Transhepatic Cholangiopancreatoscopy (PTCS) in Complex Pancreaticobiliary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580940
• Other study ID #: E7160
• Status: Completed
• Start date: July 27, 2021
• Est. completion date: January 14, 2023

Study information

• Verified date: November 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 14, 2023
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Diseases
• Bile Duct Obstruction
• Cholestasis
• Pancreatic Diseases

Intervention

Device:
• SpyGlass™ Discover Digital System
Observational, prospective, registry study for the clinical utility of the SpyGlass Discover digital catheter during a PTCS procedure.

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Brussels
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario
Germany	Evangelisches Krakenhaus Düsseldorf	Düsseldorf
Hong Kong	Prince of Wales Hospital	Shatin	NewTerritories
India	Asian Institute of Gastroenterology	Hyderabad	Somajiguda
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Hong Kong,  India,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Procedural Time	Time elapsed between first insertion to last removal of the SpyGlass™ Discover digital catheter	During index procedure
Secondary	Number of PTCS procedures	Number of PTCS procedures required to achieve clinical success until the end of follow-up	1 month
Secondary	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