Inclusion Criteria:

1. Provision to sign and date the consent form;
2. Adult patients ≥ 21 years old;
3. Any patient who is required to undergo endoscopic retrograde cholangiopancreatography (ERCP) procedure with the clinical need to perform cholangioscopy for:

1. Indeterminate biliary stricture, or
2. Failed biliary stone extraction with conventional techniques.
4. Willing and able to follow study procedures and comply with study follow-up.

Exclusion Criteria:

1. Pregnancy or lactation;
2. Surgically or physiologically altered GI anatomy that precludes advancement of the duodenoscope for biliary cannulation;
3. Patients on anti-coagulants and anti-platelet medications that cannot be withheld pre-procedure, except for aspirin, 81mg;
4. Coagulopathy (INR \> 1.8) or thrombocytopenia (Platelets \< 50,000) that is not correctable and felt to be a contraindication to proceeding with biopsy or lithotripsy per the treating endoscopist;
5. Active suppurative cholangitis with evidence of purulent drainage at the time of papilla visualization;
6. Patients who are not candidates for anesthesia to permit ERCP.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 08/25/2025. Questions regarding updates should be directed to the study team contact.