Outcomes
SECONDARY
The primary end point was the ability to complete the ERCP procedures for the intended indication(s). The secondary end points were: (i) the incidence of crossover from the single-use duodenoscope to a reusable duodenoscope; (ii) comparison of outcomes by ASGE grade, endoscopist level of experience, or prior sphincterotomy; (iii) endoscopist ratings of overall satisfaction with the single-use duodenoscope on a scale of 1 (worst) to 10 (best); (iv) serious AEs (SAEs) related to the device and/or procedure, assessed through to 30 days after the ERCP or other duodenoscope-based procedure.