Status:
COMPLETED
Infection Control in ERCP Using a Duodenoscope With a Disposable Cap
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Medical University of South Carolina
Conditions:
Bile Duct Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
1. Background \& Rationale Over 650,000 endoscopic retrograde cholangio-pancreatography (ERCP) procedures are performed annually in the United States alone. ERCP is universally performed using a h...
Detailed Description
There are two co-primary objectives of this study; the first is to determine the clinical efficacy of a novel duodenoscope with a disposable elevator cap (DECTM) system compared with a duodenoscope wi...
Eligibility Criteria
Inclusion
- age 18 years or over;
- ability to give informed consent to involvement;
- requirement for ERCP to be performed for any indication.
Exclusion
- age \< 18 years;
- inability or unwillingness to provide informed consent;
- standard contraindications to ERCP;
- pregnant status or breastfeeding mother;
- inability to successfully complete procedure under conscious sedation;
- out-of-province status;
- incarceration.
Key Trial Info
Start Date :
December 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT04040504
Start Date
December 3 2019
End Date
March 31 2022
Last Update
June 28 2022
Active Locations (1)
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1
Peter Lougheed Centre
Calgary, Canada