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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Procedure is performed using the Beacon Platform
The Hill Clinic
Sofia, Bulgaria
RECRUITINGClinica Universidad Católica
Santiago, Chile
RECRUITINGHospital Clínico Universidad de Chile
Santiago, Chile
RECRUITINGSuccessful completion of the enucleation phase of HoLEP with the Beacon Platform
Successful completion of the enucleation phase of HoLEP without the need to convert to conventional (non-robot-assisted) HoLEP, or an alternative surgical procedure for treatment of BPH-related LUTS. This excludes the use of other devices for hemostasis or dissecting the enucleated tissue during or after the procedure and cases identified by the urologist that require conversion to a non-HoLEP procedure due to factors unrelated to the device performance.
Time frame: Perioperative
The rate of successful endoscopic access to and visualization of the predefined anatomical landmarks in the urinary tract in a non-inferior fashion compared to standard rigid diagnostic cystoscopy.
The rate of successful endoscopic access to and visualization of the predefined anatomical landmarks in the urinary tract in a non-inferior fashion compared to standard rigid diagnostic cystoscopy. The key landmarks included: * Verumontanum * External Sphincter * Apical plane (between sphincter \& adenoma) * Lobes of the prostate * Bladder neck * Bilateral ureteric orifices * The lateral, posterior, and anterior bladder walls. Success is defined as the Beacon Platform achieving clear visualization and scope proximity to all landmarks deemed non-inferior to standard non-robotic rigid cystoscopy as judged by the operating surgeon using a Likert scale assessment tool at the time of the procedure. Failure is defined as inability to visualize/access any landmark due to technical factors.
Time frame: Perioperative
Rate of procedure related adverse events (AEs)
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.
Time frame: Through study completion, an average of 30 days
Incidence of bladder perforation or capsular perforation leading to interruption of the procedure or conversion to conventional HoLEP or other alternative procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Canterbury Urology Research Trust
Christchurch, New Zealand
RECRUITINGTauranga Urology Research Ltd
Tauranga, New Zealand
RECRUITINGTime frame: Perioperative
Incidence of ureteric orifice damage leading to stricture, stenting of the ureter, or other sequelae or subsequent intervention
Time frame: 30 days
Duration of hospital stay following the procedure
Time frame: 30 days
Duration of catheterization following the procedure
Time frame: 30 days
Total enucleation time
Time frame: Perioperative
Incidence of repeat hospitalization for genitourinary conditions within 30 days post procedure
Time frame: 30 days