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SpyGlass™ Discover Percutaneous

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ClinicalTrials.gov Identifier: NCT04580940
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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

Condition or disease Intervention/treatment
Pancreatic Diseases Bile Duct Obstruction Bile Duct Diseases Device: SpyGlass™ Discover Digital System

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Flexible Percutaneous Transhepatic Cholangiopancreatoscopy (PTCS) in Complex Pancreaticobiliary Disease
Actual Study Start Date : July 27, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : July 2022
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with complex pancreaticobiliary disease
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04580940


Contacts
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Contact: Danielle Vannan, PhD 1 (774) 249-5711 danielle.vannan@bsci.com
Contact: Srey Yin 1 (978) 364-6366 srey.yin@bsci.com

Locations
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United States, California
Stanford University Medical Center Not yet recruiting
Stanford, California, United States, 94305
Contact: Monique Barakat, MD, PhD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Mehran Fotoohi, MD, PhD         
Argentina
DAICIM Foundation Not yet recruiting
Caba, Argentina, 1425
Contact: Mariano Gimenez, MD, PhD         
Belgium
Erasme University Hospital Recruiting
Brussels, Belgium, 1070
Contact: Daniel Blero, MD, PhD         
Brazil
Hospital das Clinicas Not yet recruiting
São Paulo, Brazil, 05403
Contact: Eduardo De Moura, MD, PhD         
Canada, Ontario
Toronto General Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5G2N2
Contact: Eran Shlomovitz, MD, PhD         
Germany
Evangelisches Krakenhaus Düsseldorf Recruiting
Düsseldorf, Germany, 40217
Contact: Torsten Beyna, MD, PhD         
Hong Kong
Prince of Wales Hospital Recruiting
Shatin, NewTerritories, Hong Kong, 999077
Contact: James Lau, MD, PhD         
India
Asian Institute of Gastroenterology Not yet recruiting
Hyderabad, Somajiguda, India, 500-082
Contact: Mohan Ramchandani, MD, PhD         
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Recruiting
Roma, Italy, 00168
Contact: Ivo Boskoski, MD, PhD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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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: Daniel Blero, 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
Principal Investigator: Eduardo De Moura, MD, PhD Hospital das Clinicas, Sao Paolo
Principal Investigator: Mariano E Gimenez, MD, PhD DAICIM Foundation
Principal Investigator: Monique Barakat, MD, PhD Stanford University
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04580940    
Other Study ID Numbers: E7160
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022

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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
Keywords provided by Boston Scientific Corporation:
Percutaneous transhepatic cholangiopancreatoscopy
spyglass discover
pancreaticobiliary disease
Additional relevant MeSH terms:
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Pancreatic Diseases
Cholestasis
Bile Duct Diseases
Digestive System Diseases
Biliary Tract Diseases