Title
The Histosonics Edison System for Treatment of Primary Solid Renal Tumors Using Histotripsy

Description
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.

Objective
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.

Treatment This trial is a prospective, multi-center, single-arm pivotal trial designed to evaluate the effectiveness and safety of the HistoSonics Edison System for the destruction of kidney tissue by treating primary solid renal tumors. Data through 90 days for all enrolled subjects will be summarized in a primary analysis to be submitted for Regulatory Submission to the FDA. Additionally, subjects will be followed for five (5) years post-index procedure, with evaluations at the 14-day, 30-day, 90-day, 180-day and annual time points.

Key Eligibility Inclusion Criteria:

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
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)

White Blood Count (WBC)
Albumin


Subject has an eGFR (Glomerular filtration rate) >/=45mL/min,
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.

Applicable Disease Sites
Kidney

Participating Institutions
UW Health University Hospital