SpyGlass™ Discover Percutaneous
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | 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
Primary Outcome Measures
- 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
- 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
- Number of PTCS procedures [1 month]
Number of PTCS procedures required to achieve clinical success until the end of follow-up
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University Medical Center | Stanford | California | United States | 94305 |
| 2 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
| 3 | DAICIM Foundation | Caba | Argentina | 1425 | |
| 4 | Erasme University Hospital | Brussels | Belgium | 1070 | |
| 5 | Hospital das Clinicas | São Paulo | Brazil | 05403 | |
| 6 | Toronto General Hospital, University Health Network | Toronto | Ontario | Canada | M5G2N2 |
| 7 | Evangelisches Krakenhaus Düsseldorf | Düsseldorf | Germany | 40217 | |
| 8 | Prince of Wales Hospital | Shatin | NewTerritories | Hong Kong | 999077 |
| 9 | Asian Institute of Gastroenterology | Hyderabad | Somajiguda | India | 500-082 |
| 10 | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | Italy | 00168 |
Sponsors and Collaborators
- 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
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E7160