Spy II Clinical Registry

A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System

A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.

Inclusion Criteria:

• Male or female >= 18 years of age
• Willing and able to comply with the Registry procedures and provide written informed consent to participate in the Registry
• Indicated for ERCP or ERCP/cholangioscopy (with or without biopsy)

Exclusion Criteria:

• Subjects for whom endoscopic procedure are medically contraindicated
• Subjects for whom ERCP are medically contraindicated
• Subjects for whom medical condition warrants use of device outside of indication for use