A Pilot, Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
This single-arm study aims to evaluate the Beacon Platform, an advancement in urological surgery. The study will assess its intraoperative and postoperative outcomes. The aim of this investigation is to establish safety and performance of the Beacon Platform.
• Male
• Subject has diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction,
• Subject is able and willing to comply with all the assessments of the study,
• Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the informed consent form,
• ≥ 45 years of Age,
• Prostate volume 30 cc to 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within 180 days prior to procedure,
• The subject is indicated for undergoing HoLEP procedure