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

Prior treatment

• 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).
• 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.
• Subject is taking Aspirin (ASA) or NSAIDS ≤7 days prior to the planned index procedure date.
• Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.
• Subject's targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, radiation).
• Subject has a urinary tract infection (UTI) ≤7 days prior to the planned index procedure date.

Other illness

• Subjects who have active cancers (not in remission for the last two years) other than non-melanomatous skin cancers.
• 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.
• Subject is on dialysis, being considered for dialysis or has acute renal failure.
• 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

Lab values

• 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.

Other

• Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
• Subject has a life expectancy less than one (\< 1) year.
• In the investigator's opinion, histotripsy is not a treatment option for the subject.
• Subject's targeted tumor is not treatable by the HistoSonics Edison System's working ranges (refer to User Guide).
• In the investigator's opinion, the anticipated risks of intervention outweigh the potential benefits of the intervention.
• Subject has bilateral kidney tumors or has a single functioning kidney.
• The targeted tumor is an angiomyolipoma.
• Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
• The targeted tumor is not clearly visible with ultrasound, MRI or CT.
• Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel, ureter, organ or other vital structure.
• The treatment of the tumor will not allow an adequate margin (as determined by the investigator).

• Subject is ≥22 years of age.
• 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.
• 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.
• Subject has had a biopsy to determine the type of tumor, ≥14 days prior to the index procedure.
• Subject can tolerate general anesthesia.
• Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening.
• 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)
• Subject has an eGFR (Glomerular filtration rate) ≥45mL/min, ≤14 days prior to the planned index procedure date.
• The tumor selected for histotripsy treatment must be ≤3cm in longest diameter.
• Subject has an adequate acoustic window to visualize targeted tumor using the HistoSonics Edison System.