Robotic assisted surgery for benign prostatic hyperplasia (BPH)
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,
Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,
History of prostate cancer or current/suspected bladder cancer,
Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds,
History of other diseases causing voiding dysfunction including urinary retention (e.g., diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
Single group
Beacon Platform
DeviceThe Beacon Platform is a robotically assisted surgical (RAS) device. It enables the urologist, through software, to control and move surgical instruments for a variety of transurethral, endoscopic procedures
Number of Participants Successfully Completing Robot-Assisted HoLEP (Enucleation and Morcellation) Without Conversion
This endpoint measures the number of participants who successfully complete both the enucleation and morcellation phases of robot-assisted HoLEP (Holmium Laser Enucleation of the Prostate) without the need to convert to a conventional HoLEP or an alternative surgical procedure for treating BPH-related LUTS.Successful completion is defined as completing both phases without using additional devices . This excludes the Roll-in subjects and the use of other devices for hemostasis or dissecting the enucleated tissue during or after the procedure.
Number of subjects with adverse events ( Clavien-Dindo Grade 3a or higher )
Proportion of subjects with adverse events rated as probably or definitely related to the study procedure (robot-assisted HoLEP or RoLEP) classified as Clavien-Dindo Grade 3a or higher through 30 days post-treatment.
Number of Participants with Capsular Perforation Leading to Procedure Interruption or Conversion
This outcome measures the incidence of capsular perforation events that result in interruption of the procedure or conversion to conventional HoLEP or an alternative surgical procedure
Number of Participants with Bladder Perforation Leading to Procedure Interruption or Conversion
This outcome measures the incidence of bladder perforation events that result in interruption of the procedure or conversion to conventional HoLEP or an alternative surgical procedure.
Number of Participants with Ureteric Orifice Damage Requiring Intervention
This outcome assesses the incidence of ureteric orifice damage leading to stricture, stenting, or any other sequelae or subsequent intervention.
Length of Hospital Stay Post-Procedure
This outcome measures the total length of hospital stay required following the HoLEP procedure.
Duration of Enucleation and Morcellation Phases
This outcome measures the combined time taken to complete the enucleation and morcellation phases of the HoLEP procedure.
Number of Participants Requiring Blood Transfusion Post-Procedure
This outcome tracks the incidence of blood transfusion events following the HoLEP procedure.
Number of Participants Requiring Secondary Reintervention with HoLEP or Alternative Surgical Therapy
This outcome measures the incidence of participants requiring a secondary reintervention using HoLEP or an alternative surgical therapy for LUTS within 30 days post-procedure.
Incidence Rate of Stress Urinary Incontinence Post-Procedure
This outcome assesses the rate of stress urinary incontinence among participants within 30 days following the procedure.
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