An interventional study of Beacon Platform in BPH (Benign Prostatic Hyperplasia) and HoLEP (Holmium Laser Enucleation of Prostate), sponsored by Andromeda Surgical. Recruiting at 5 sites in 3 countries. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Andromeda Surgical · Not applicable, Interventional, and Treatment
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 50 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Andromeda Surgical is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will undergo the procedure with the Beacon Platform
Device: Beacon Platform
Procedure is performed using the Beacon Platform
Successful 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
Time 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
Started Sep 2025 (actual). Primary completion is estimated for Dec 2026, 15 months after the start.
Of 51 industry-sponsored interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 50. This study's planned 15 months is below that.
Counting every sponsor, half of 203 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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