HOPE4KIDNEY: The HistoSonics Edison System for treatment of primary solid renal tumors using histotripsy (#HOPE4KIDNEY US)

Study Purpose: The purpose of this trial is to evaluate the effectiveness and safety of the HistoSonics Edison System for the destruction of kidney tissue by treating primary solid renal tumors.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if
you meet the following criteria:

Study Duration: The duration of this trial is expected to be approximately seven (7) years.

Study Commitment:
Tell the study doctor about your medical history
Attend all visits scheduled with the study doctor
Call the study doctor’s office to reschedule a missed visit as soon as possible
Report any injuries, hospitalizations, emergency room visits, symptoms or complaints to the study doctor or nurse as soon as possible.
To participate in the study, you must be willing and agree to have all the required tests done before and after the procedure. You will be expected to be available for testing, follow-up visits and telephone call(s) at your study doctor’s office as described below.

Age: Over 22 years old

Sex: Male & Female

Conditions/Eligibility:
General Inclusion
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 ≥45mL/min, ≤14 days prior to the planned index procedure date.
Index-Procedure Imaging Inclusion (Assessed day of procedure)
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.

General Exclusion
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 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 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.
Index-Procedure Imaging Exclusion (Assessed day of procedure)
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 for an adequate margin (as determined by the investigator).

Study Procedures:
Medical History
Physical Exams
Renal Biopsy (if not previously done in the past year)
R.E.N.A.L Nephrometry Score
ECOG PS Grade
NFSKI-19 Questionnaire
Numeric Rating Scale
Blood tests (include CBC, Liver enzyme panel, INR value, metabolic panel, liver function tests [albumin] serum creatinine, serum pregnancy test)
Urinalysis
Imaging (may include either CT or MRI)
Histotripsy treatment

Compensation: You will be reimbursed for certain costs you acquire by participating in this study (i.e., travel and meals). Some expenses must be pre-approved after providing receipts. Please discuss expected costs with your study team.