Study of the Beacon Robot-Assisted Platform for Holmium Laser Surgery in Men with Benign Prostatic Enlargement

What this Trial Is About

This research aims to evaluate the Beacon Platform, a robotically assisted surgical device, for treating benign prostatic hyperplasia BPH in men. The study focuses on observing the outcomes of the Holmium Laser Enucleation of the Prostate HoLEP procedure using this platform. It is a prospective, multicenter, open-label pilot study designed to gather information on both intraoperative and postoperative results. Participants will undergo the HoLEP procedure assisted by the Beacon Platform, which allows the urologist to control surgical instruments through software during transurethral, endoscopic surgery. This single-arm study monitors the procedure without comparing to other treatments. The study tracks outcomes such as successful completion of the robot-assisted surgery without conversion and adverse events occurring up to 30 days after the procedure. During the study, participants will be closely monitored for safety and effectiveness through various assessments, including length of hospital stay, catheterization duration, operative time, and any complications such as perforations or damage requiring intervention. Researchers will also observe hospital readmissions related to genitourinary conditions within 30 days following the surgery. Participant involvement includes signing informed consent, undergoing the procedure, and completing follow-up evaluations until the study concludes.

A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)