Exalt D Single-use Duodenoscope in ERCP Procedures in China

Device Description：The Exalt™ Model D Single-Use Duodenoscope is a sterile, single-use endoscope that facilitates access to the duodenum, delivery of accessories, and live video when connected to an Exalt™ Controller. The Exalt™ Controller is an electronic device that: * Receives video signals from a Boston Scientific single-use endoscope, * Processes the video signals, * Outputs video images to a video monitor, and * Outputs electrical signal(s) that interface with external image capture systems. Study Design：This is a prospective, single-arm study with up to 35 subjects to satisfy 30 treated cohort in up to 3 centers. The study duration is expected to be approximately 7 months, assuming 6 months enrollment and 1 month follow up. The study duration for each subject is expected to be approximately 30 days. Data Analyses：All statistical analyses will be done using The SAS System software, version 8 or higher (Copyright © 2000 SAS Institute Inc., SAS Campus Drive, Cary, North Carolina 27513, USA. All rights reserved).