SpyGlass™ Discover Percutaneous

November 27, 2023 updated by: Boston Scientific Corporation

Flexible Percutaneous Transhepatic Cholangiopancreatoscopy (PTCS) in Complex Pancreaticobiliary Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Erasme University Hospital
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G2N2
        • Toronto General Hospital, University Health Network
  • Germany
      • Düsseldorf, Germany, 40217
        • Evangelisches Krakenhaus Düsseldorf
  • Hong Kong
    • NewTerritories
      • Shatin, NewTerritories, Hong Kong, 999077
        • Prince of Wales Hospital
  • India
    • Somajiguda
      • Hyderabad, Somajiguda, India, 500-082
        • Asian Institute Of Gastroenterology
  • Italy
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with complex pancreaticobiliary disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with complex pancreaticobiliary disease
All subjects will undergo the percutaneous transhepatic cholangiopancreatoscopy with the SpyGlass Discover System.
Device: SpyGlass™ Discover Digital System
Observational, prospective, registry study for the clinical utility of the SpyGlass Discover digital catheter during a PTCS procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 month
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
During index procedure
Procedural Time
Time Frame: During index procedure
Time elapsed between first insertion to last removal of the SpyGlass™ Discover digital catheter
During index procedure
Number of PTCS procedures
Time Frame: 1 month
Number of PTCS procedures required to achieve clinical success until the end of follow-up
1 month
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
During index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Ivo Boskoski, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Principal Investigator: Torsten Beyna, MD, PhD, Evangelisches Krakenhaus Düsseldorf
  • Principal Investigator: Mehran Fotoohi, MD, PhD, Virginia Mason
  • Principal Investigator: Arnaud Lemmers, MD, PhD, Erasme University Hospital
  • Principal Investigator: James Lau, MD, PhD, Prince of Wales Hospital
  • Principal Investigator: Eran Shlomovitz, MD, PhD, Toronto General Hospital, University Health Network
  • Principal Investigator: Mohan Ramchandani, MD, PhD, Asian Institute Of Gastroenterology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2021

Primary Completion (Actual)

December 14, 2022

Study Completion (Actual)

January 14, 2023

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7160

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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