The purpose of this trial is to evaluate the safety of histotripsy using the HistoSonics Edison System for treatment of BPH.
Subject is ≥ 50 years of age.
Subject has signed the Ethics Committee (EC) 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 BPH.
Subject has a Body Mass Index (BMI) < 27.
Subject has a life expectancy of less than one (1) year.
Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
Subject has a post-void residual ≥ 150 mL confirmed via ultrasound.
Subject has an estimated glomerular filtration rate (eGFR) ≤ 50 mL/min, ≤ 14 days prior to the planned index procedure date.
Single group
HistoSonics Edison System
DeviceThe HistoSonics Edison System is intended for the non-invasive mechanical destruction of prostate tissue for the treatment of BPH using histotripsy, a non-thermal, mechanical process of focused ultrasound.
Number of Index-Procedure Related Adverse Events Classified by Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE)
Index procedure-related complications ≤30 days post index procedure, graded using Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE). \[Clinical Events Committee Adjudicated\]
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