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OpenTrials
Completed

NCT Number: NCT04580940

SpyGlass™ Discover Percutaneous

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

Completed

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Key information

Conditions

Pancreatic Diseases Bile Duct Diseases Bile Duct Obstruction Biliary Tract Diseases Cholestasis Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme University Hospital, Brussels, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SpyGlass™ Discover Digital System

Device

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

Primary outcomes

  1. Achieving clinical intent of procedure as indicated

    Time frame: 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 outcomes

  1. Number of Adverse Events

    Time frame: 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).

  2. Technical success

    Time frame: During index procedure

    Rate at which SpyGlass™ Discover digital catheter can be advanced to the target lesion or stone(s) and visualize the target

  3. Procedural Time

    Time frame: During index procedure

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

  4. Number of PTCS procedures

    Time frame: 1 month

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

  5. Endoscopist rating

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Flexible Percutaneous Transhepatic Cholangiopancreatoscopy (PTCS) in Complex Pancreaticobiliary Disease

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 9, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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