Global Prospective Case Series Using a Single-Use Duodenoscope
NCT ID: NCT04103749
Last Updated: 2023-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
551 participants
INTERVENTIONAL
2021-03-22
2023-01-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Exalt DScope 02
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
Exalt Model D Single-Use Duodenoscope
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
Interventions
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Exalt Model D Single-Use Duodenoscope
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
Eligibility Criteria
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Inclusion Criteria
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
* Scheduled for a clinically indicated ERCP
Exclusion Criteria
* Subjects for whom endoscopic techniques are contraindicated
* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
* Investigator discretion
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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Adam Slivka, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center
Marco Bruno, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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University of California Los Angeles Medical Center
Los Angeles, California, United States
University of Chicago
Chicago, Illinois, United States
Indianapolis University Hospital
Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
North Shore University Hospital
Manhasset, New York, United States
Cornell Medical Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Metro North Hospital and Health Services
Brisbane, , Australia
St. Michael's Hospital - Unity Health
Toronto, , Canada
Institut Paoli-Calmettes
Marseille, , France
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Prince of Wales Hospital
Hong Kong, , Hong Kong
Asian Institute of Gastroenterology
Hyderabad, Telangana, India
Apollo Multispeciality Hospitals
Kolkata, West Bengal, India
Humanitas University
Milan, , Italy
Erasmus University Medical Center of Rotterdam
Rotterdam, , Netherlands
Singapore General Hospital
Singapore, , Singapore
Dr. George Mukhari Academic Hospital
Ga-Rankuwa, , South Africa
Countries
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References
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Bruno MJ, Beyna T, Carr-Locke D, Chahal P, Costamagna G, Devereaux B, Giovannini M, Goenka MK, Khor C, Lau J, May G, Muthusamy VR, Patel S, Petersen BT, Pleskow DK, Raijman I, Reddy DN, Repici A, Ross AS, Sejpal DV, Sherman S, Siddiqui UD, Ziady C, Peetermans JA, Rousseau MJ, Slivka A; EXALT Single-use Duodenoscope Study Group. Global prospective case series of ERCPs using a single-use duodenoscope. Endoscopy. 2023 Dec;55(12):1103-1114. doi: 10.1055/a-2131-7180. Epub 2023 Jul 18.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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E7156
Identifier Type: -
Identifier Source: org_study_id