Global Prospective Case Series Using a Single-Use Duodenoscope

Global Prospective Case Series Using a Single-Use Duodenoscope

Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures

This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. Up to 1000 cases will be included at up to 40 clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated ERCP procedure performed using the study device. Enrolled subjects will be followed for 30 days after their procedure.

Inclusion Criteria:

• 18 years or older
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study
• Scheduled for a clinically indicated ERCP

Exclusion Criteria:

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