Clinical Research Directory

Inclusion Criteria: 1. Diagnosis of calyceal and/or renal pelvis calculi 2. Age from 18 through 85 years 3. Maximum stone diameter between 0.5cm - 2.0cm as assessed by Non-Contrast CT scan (≤ 2 mm slice thickness) within 90 days prior to treatment 4. Willing and able to comply with all study requirements 5. Signs study-specific informed consent form Exclusion Criteria: 1. Diagnosis of calculus of the ureter 2. BMI ≥ 42 3. Significant renal impairment: stage 3a CKD or higher (eGFR \<59mL/min) 4. Active infection, including urinary tract infection 5. Urological anatomic/congenital abnormalities 6. Previous history of struvite stone in the same renal unit 7. Taking anticoagulants that cannot be stopped before and after procedure or known coagulopathy or platelet disorder (except aspirin below 100mg/d) 8. History of gross hematuria 9. Solitary functioning kidney 10. Known allergy to device materials 11. Any severe illness that would prevent complete study participation or confound study results 12. Serious concurrent medical conditions such as heart disease (e.g., myocardial infarction within 30 days, congestive heart failure - NYHA Class IV), pulmonary disease or uncontrolled diabetes. 13. History of open-heart surgery, or cardiac arrest \< 180 days prior to the date of informed consent 14. ASA III or higher 15. Taking systemic immune suppressants 16. Dementia or psychiatric condition that prevents the participant from completing required follow up 17. Contraindication to both general and spinal anesthesia 18. Participating in another investigational study that could affect responses to the study device 19. Unwilling to accept a transfusion should one be required 20. Pregnant or considering getting pregnant within the next 3 months 21. Undergoing bilateral ureteroscopy