The HistoSonics Edison™ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY)

Eligibility Criteria

• 1. Subject is ≥22 years of age.
• 2. Subject has signed the Institutional Review Board (IRB) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments.
• 3. Subject is diagnosed with only one (1) non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤30 days prior to the index procedure date.
• 4. Subject has had a biopsy to determine the type of tumor, ≥14 days prior to the index procedure.
• 5. Subject can tolerate general anesthesia.
• 6. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening.
• 7. Subject meets all the following functional criteria at ≤14 days prior to the planned index procedure date:
• * White Blood Count (WBC) ≥3,000/mm3 (≥3 10\*9/L)
• * Absolute Neutrophil Count (ANC) ≥1,200/mm3 (≥1.2 10\*9/L)
• * Hemoglobin (Hgb) ≥9 g/dL
• * Platelet count ≥100,000/mm3 (≥100 10\*9/L)
• * White Blood Count (WBC) ≤5 hpf via urinalysis
• * Albumin ≤300 mg/g via urinalysis
• 8. Subject has an eGFR (Glomerular filtration rate) ≥45mL/min, ≤14 days prior to the planned index procedure date.
• 9. The tumor selected for histotripsy treatment must be ≤3cm in longest diameter.
• 10. Subject has an adequate acoustic window to visualize targeted tumor using the HistoSonics Edison System.
• 1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
• 2. Subject is being actively treated in another pharmaceutical or device trial ≤30 days prior to planned index procedure date that may interfere with the primary endpoint(s).
• 3. Subjects who have active cancers (not in remission for the last two years) other than non-melanomatous skin cancers.
• 4. In the Investigator's opinion, the subject has co-morbid disease(s) or condition(s) that would cause undue risk and preclude safe use of the HistoSonics Edison System.
• 5. Subject is on dialysis, being considered for dialysis or has acute renal failure.
• 6. Subject has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or better from any adverse effects (except alopecia and neuropathy) related to previous therapy.
• 7. Subject has an International normalized ratio (INR) \>1.5 or uncorrectable coagulopathy, (e.g., known von Willebrand disease, hemophilia, or on anticoagulants), on the planned index procedure date.
• 8. Subject is taking Aspirin (ASA) or NSAIDS ≤14 days prior to the planned index procedure date.
• 9. Subject has a life expectancy less than one (\< 1) year.
• 10. In the investigator's opinion, histotripsy is not a treatment option for the subject.
• 11. Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.
• 12. Subject's targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, radiation).
• 13. Subject's targeted tumor is not treatable by the HistoSonics Edison System's working ranges (refer to User Guide).
• 14. In the investigator's opinion, the anticipated risks of intervention outweigh the potential benefits of the intervention.
• 15. Subject has bilateral kidney tumors or has a single functioning kidney.
• 16. Subject has a genetic predisposition to kidney cancer such as:
• * Von Hippel Lindau (VHL)
• * Hereditary Papillary Renal Carcinoma (HPRC)
• * Birt-Hogg-Dubé Syndrome (BHD)
• * Tuberous Sclerosis Complex (TSC)
• * Hereditary Leiomyomata's Renal Cell Carcinoma (HLRCC)
• * Reed's Syndrome
• * Succinate Dehydrogenase B Deficiency (SDHB)
• * BRCA 1 associated protein -1 (BAP1) Renal Cell Carcinoma
• * MITF predisposed Renal Cell Carcinoma
• 17. The targeted tumor is an angiomyolipoma.
• 18. Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
• 19. The targeted tumor is not clearly visible with ultrasound, MRI or CT.
• 20. Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel, ureter, or other vital structure.
• 21. The treatment of the tumor will not allow an adequate margin (as determined by the investigator).