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

Exclusion Criteria

• •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 ≤7 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. Subject has a urinary tract infection (UTI) ≤7 days prior to the planned index procedure date.
• •20. The targeted tumor is not clearly visible with ultrasound, MRI or CT.
• •21. Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel, ureter, organ or other vital structure.
• •22. The treatment of the tumor will not allow an adequate margin (as determined by the investigator).