DISON I Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis- A Multicenter Prospective Pilot Study

Inclusion criteria

• Diagnosis of calyceal and/or renal pelvis calculi
• Age from 18 through 85 years
• 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
• Willing and able to comply with all study requirements
• Signs study-specific informed consent form

Exclusion criteria

• Diagnosis of calculus of the ureter
• BMI ≥ 42
• Significant renal impairment: stage 3a CKD or higher (eGFR <59mL/min)
• Active infection, including urinary tract infection
• Urological anatomic/congenital abnormalities
• Previous history of struvite stone in the same renal unit
• Taking anticoagulants that cannot be stopped before and after procedure or known coagulopathy or platelet disorder (except aspirin below 100mg/d)
• History of gross hematuria
• Solitary functioning kidney
• Known allergy to device materials
• Any severe illness that would prevent complete study participation or confound study results
• 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.
• History of open-heart surgery, or cardiac arrest < 180 days prior to the date of informed consent
• ASA III or higher
• Taking systemic immune suppressants
• Dementia or psychiatric condition that prevents the participant from completing required follow up
• Contraindication to both general and spinal anesthesia
• Participating in another investigational study that could affect responses to the study device
• Unwilling to accept a transfusion should one be required
• Pregnant or considering getting pregnant within the next 3 months
• Undergoing bilateral ureteroscopy