To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic Benign Prostate Hyperplasia (BPH) Also Known as an Enlarged Prostate.

The main goal of this study is to evaluate the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System for treatment of enlarged prostate (BPH) symptoms. The study will involve up to 250 male participants who have urinary problems caused by BPH and whom are greater than 40 years of age in up to 30 investigational centers across the US,Canada and European Union.

NCT Number	NCT07592299
Lead Sponsor	ALPFA Medical
Conditions	Benign Prostatic Hyperplasia (BPH)
Enrollment	250 participants
Start Date	2026-08
Primary Completion	2028-08 (estimated)
Study Completion	2032-12 (estimated)
Updated on ClinicalTrials.gov	2026-05-18