Status:
COMPLETED
Global Prospective Case Series Using a Single-Use Duodenoscope
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Endoscopic Retrograde Cholangiopancreatography
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures
Detailed Description
This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. Up to 1000 cases will be included at up to 40 clinica...
Eligibility Criteria
Inclusion
- 18 years or older
- 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
- Potentially vulnerable subjects, including, but not limited to pregnant women
- 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
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2023
Estimated Enrollment :
551 Patients enrolled
Trial Details
Trial ID
NCT04103749
Start Date
March 22 2021
End Date
January 5 2023
Last Update
December 12 2023
Active Locations (22)
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1
University of California Los Angeles Medical Center
Los Angeles, California, United States, 90095
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Indianapolis University Hospital
Indianapolis, Indiana, United States, 46202
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215