Clinical Trials

Inclusion Criteria:

1. Subjects aged 18-89
2. Subjects with abdominal pain secondary to chronic calcific pancreatitis and main pancreatic duct stones found on cross-sectional imaging, EUS, or ERP with upstream PD dilation
3. Main PD stones in the head or body that are greater than 50% in size of the immediate downstream diameter of the pancreatic duct
4. Stones ≥ 5 mm in diameter or impacted in the main PD on cross-sectional imaging or EUS

Exclusion Criteria:

1. Subjects who have previously received PPL or ESWL for PD stones within 12 months of enrollment
2. Patients with PD stones isolated in the tail or side branches of the main duct
3. Pancreatic tail stones comprising more than one-third of the stone burden within the main PD, if multiple locations of stones are noted within the main PD
4. Nontraversable ansa loop with upstream stones
5. Inability to place a transpapillary pancreatic duct stent during ERP
6. Patients with prior pancreatic surgery or surgically altered gastroduodenal anatomy, such as Roux-en-Y surgery
7. Acquired pancreas divisum
8. Significant cardiopulmonary co-morbidities precluding general anesthesia
9. Patients with coagulation disorders that cannot be corrected to an INR below 2.0
10. Patients with ongoing alcohol abuse and/or illicit drug use, except products containing THC
11. Pregnancy
12. Patients in active treatment for malignancy other than non-melanoma skin cancer or papillary thyroid cancer

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

Eligibility last updated 4/07/2025. Questions regarding updates should be directed to the study team contact.