Ability to complete ERCP for intended indication
DILATION

Among the 551 study cases, 529 (96.0 %, 95 %CI 94.0 %–97.5 %) were completed for the intended indication, including 503 (91.3 %, 95 %CI 88.6 %–93.5 %) using only the single-use duodenoscope, and 26 (4.7 %, 95 %CI 3.1 %–6.8 %) including crossover from the single-use to a reusable duodenoscope. Of the 22 cases that were not completed, 11 included crossover to a reusable duodenoscope (

A total of 514 patients (93.3 %) underwent an ERCP procedure that used the single-use duodenoscope only (
For 524 patients (95.1 %), all of the intended maneuvers were completed. Over 20 different types of maneuvers were performed using the single-use duodenoscope, including sphincterotomy, papillectomy/ampullectomy, cannulation, mechanical lithotripsy, clearance of bile duct or pancreatic duct stones, biliary or pancreatic stent placement or removal, balloon dilation, cholangioscopy (n = 24), pancreatoscopy (n = 9), cytology brushing, biopsy, and others. Pancreatic maneuvers were performed in 128 patients (23.2 %).