This pilot study will evaluate the initial safety and effectiveness of Irreversible Electroporation (IRE) using the NanoKnife System for the treatment of symptomatic benign prostatic hyperplasia (BPH). It is a prospective, non-randomized study enrolling 40 subjects at up to five U.S. clinical sites, with follow-up through 5 years post-treatment.
Key Endpoints:
- The primary effectiveness endpoint is the mean change in International Prostate Symptom Score (IPSS) from baseline to 6 months post-procedure, assessing improvement in lower urinary tract symptoms attributable to benign prostatic hyperplasia (BPH).
- The primary safety endpoint is the incidence and severity of device-related adverse events (AEs) through 6 months post-procedure.
Full study information can be found on ClinicalTrials.gov under identifier NCT07640776.