Patient population
RECRUITMENT

The study protocol allowed for recruitment of adult patients scheduled for ERCP per the standard of care at up to 40 participating healthcare centers. Eligible patients were recruited for the study on selected weekdays when participating endoscopists were performing ERCPs. Patients were eligible for inclusion if they were aged ≥ 18 years, willing and able to comply with the study procedures and to provide written informed consent to participate in the study, and were scheduled for a clinically indicated ERCP or other duodenoscope-based procedure. Excluded from the study were potentially vulnerable patients including, but not limited to: pregnant women, patients for whom endoscopic techniques were contraindicated, patients enrolled in another investigational study that would directly interfere with the current study, and patients excluded at investigator discretion. Unlike previous studies of the single-use duodenoscope, the current study included patients with “altered pancreaticobiliary anatomy” because this was not a contraindication in the Directions for Use approved in 2020
