Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience

Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience

The objective of this study is to confirm procedural performance of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures.

The main objective of this study to confirm the design and operating specifications of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures in study subjects.

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 endoscopic retrograde cholangiopancreatography (ERCP)

Exclusion Criteria:

• Altered pancreaticobiliary anatomy
• 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