This study will evaluate the safety and effectiveness of using Irreversible Electroporation (IRE) for the treatment of symptomatic benign prostatic hyperplasia (BPH).
Male, age ≥50 years.
Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH).
International Prostate Symptom Score (IPSS) ≥13 at screening.
Peak urinary flow rate (Qmax) ≤12 mL/sec on non-catheterized free flow with voided volume ≥125 mL.
Patients with ≥ Grade Group 2 prostate cancer (≥ Gleason score 7).
Patients with Grade Group 1 prostate cancer (Gleason score 6) on active surveillance for less than 1 year.
Patients with PSA ≥10 ng/mL or PSA density ≥0.15 ng/mL2.
Prior surgical or minimally invasive intervention for BPH (e.g., TURP, Rezūm™, UroLift®, laser therapy).
Angiodynamics, Inc.
Lead sponsor