Strategy Adjustment

Study Objective(s)：This study is to evaluate the feasibility, preliminary safety and performance of Exalt D Single-use Duodenoscope in ERCP procedures in China, to generate local real world data from a Chinese ERCP population.

Study Design：Prospective, single-arm study Planned Number of Subjects：Up to 35 to satisfy 30 treated cohort Primary Endpoint：Ability to complete the ERCP procedure for the intended indication(s) without crossing to reusable duodenoscope.

It is also considered as Exalt D's ability if the clinical effect is the same per the investigator's judgement in case of an endoscope change (non-Exalt D).

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).

Inclusion Criteria:

1. 18 years or older
2. Willing and able to comply with the study procedures and provide written informed consent to participate in the study
3. Schedule for a clinically indicated ERCP

Exclusion Criteria:

1. Potentially vulnerable subjects, including, but not limited to pregnant women
2. Subjects for whom endoscopic techniques are contraindicated
3. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
4. Investigator discretion