Study design
This was a large, multinational case series of the performance of a single-use duodenoscope for ERCP. Institutional Review Board and Ethics Committee approvals for the study were obtained at all study sites. All enrolled patients provided written informed consent for study participation before they contributed data. Single-use duodenoscopes were provided without charge to the investigational sites for use in the study procedures.
Boston Scientific Corporation (Marlborough, Massachusetts, USA) sponsored and funded the study. Sixteen endoscopists participated in published research during development of the single-use duodenoscope
