A Single-Use Duodenoscope in a Real-World Setting

This is a prospective, non-randomized, single-arm post-market observational clinical study that will assess the single-use Ambu® aScope™ Duodeno for non-emergent, standard of care (SOC) ERCP procedures.

Inclusion criteria

• Subject is ≥ 18 years old.
• Subject is indicated and scheduled for an elective, non-emergent ERCP.
• Subject is willing and able to give informed consent and HIPAA authorization.

Exclusion criteria

• Subject has altered pancreaticobiliary anatomy including:

• Billroth II
• Roux-en-Y gastric bypass
• Loop gastric bypass
• Post-Whipple
• Roux-en-Y hepaticojejunostomy
• Subject requires an emergency ERCP (emergent decompression procedure within 6-12 hours of presentation to prevent life-threatening sequelae).
• Subject has any of the following severe co-morbid conditions

• Morbid obesity (BMI ≥ 40)
• Unstable cardiopulmonary conditions
• Severe and uncorrectable coagulopathy
• Severe and uncorrectable thrombocytopenia
• Subject has clinically significant esophageal, pyloric or duodenal strictures.
• Subject has been previously been treated under this investigational plan.
• Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
• Subject is actively taking an anticoagulant or antiplatelet agent other than aspirin.
• Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not allow the subject to be a good study candidate.