Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2021-07-27
2023-01-14
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects with complex pancreaticobiliary disease
All subjects will undergo the percutaneous transhepatic cholangiopancreatoscopy with the SpyGlass Discover System.
SpyGlass™ Discover Digital System
Observational, prospective, registry study for the clinical utility of the SpyGlass Discover digital catheter during a PTCS procedure.
Interventions
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SpyGlass™ Discover Digital System
Observational, prospective, registry study for the clinical utility of the SpyGlass Discover digital catheter during a PTCS procedure.
Eligibility Criteria
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Inclusion Criteria
2. Written informed consent from patient or legally authorized representative of the patient
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ivo Boskoski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Torsten Beyna, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Evangelisches Krakenhaus Düsseldorf
Mehran Fotoohi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Virginia Mason
Arnaud Lemmers, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasme University Hospital
James Lau, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Hospital
Eran Shlomovitz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Toronto General Hospital, University Health Network
Mohan Ramchandani, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asian Institute of Gastroenterology
Locations
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Virginia Mason Medical Center
Seattle, Washington, United States
Erasme University Hospital
Brussels, , Belgium
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada
Evangelisches Krakenhaus Düsseldorf
Düsseldorf, , Germany
Prince of Wales Hospital
Shatin, NewTerritories, Hong Kong
Asian Institute of Gastroenterology
Hyderabad, Somajiguda, India
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Countries
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References
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Boskoski I, Beyna T, Lau JY, Lemmers A, Fotoohi M, Ramchandani M, Pontecorvi V, Peetermans J, Shlomovitz E. Efficacy and safety of a single-use cholangioscope for percutaneous transhepatic cholangioscopy. Endosc Int Open. 2024 Aug 23;12(8):E981-E988. doi: 10.1055/a-2366-2265. eCollection 2024 Aug.
Aihara H, Othman MO, Jawaid SA, Gorgun E, Sharma NR, Siddiqui UD, Peetermans JA, Rousseau MJ, Nishimura M. A multicenter, retrospective study of a through-the-needle injection-capable electrosurgical knife for endoscopic submucosal dissection. Gastrointest Endosc. 2024 Dec;100(6):1034-1042. doi: 10.1016/j.gie.2024.06.011. Epub 2024 Jun 13.
Other Identifiers
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E7160
Identifier Type: -
Identifier Source: org_study_id