A Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)

NCT07741656 | Recruiting

• 1 other identifier: ASTRA 2
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 5

Brief Summary

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.

Conditions

BPH (Benign Prostatic Hyperplasia); HoLEP (Holmium Laser Enucleation of Prostate)

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Through study completion, an average of 30 days

Secondary Outcomes (6)

• Incidence of bladder perforation or capsular perforation leading to interruption of the procedure or conversion to conventional HoLEP or other alternative procedure

  Perioperative

• Incidence of ureteric orifice damage leading to stricture, stenting of the ureter, or other sequelae or subsequent intervention

  30 days

• Duration of hospital stay following the procedure

  30 days

• Duration of catheterization following the procedure

  30 days

• Total enucleation time

  Perioperative

Study Arms (1)

Procedure performed with Beacon Platform

EXPERIMENTAL

All participants will undergo the procedure with the Beacon Platform

Device: Beacon Platform

Interventions

Beacon Platform DEVICE

Procedure is performed using the Beacon Platform

Procedure performed with Beacon Platform

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,
• History of prostate cancer or diagnosed 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.),
• Subjects with overactive bladder in the absence of benign prostatic obstruction as determined by the investigator,
• Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated)
• Previous pelvic irradiation or radical pelvic surgery,
• Previous prostate surgery, including enucleation, resection, vaporization, thermotherapy, ablation, stenting, or prostatic urethral lift,
• Inability to stop taking anticoagulants for at least 3 days prior to the procedure or antiplatelets and/or coumadin for at least 5 days prior to the procedure (Note: low dose aspirin therapy is permitted), bridging anticoagulation therapy is permitted if managed per institutional guidelines and does not increase perioperative bleeding risk
• Any severe illness that would prevent complete study participation or confound study results.
• Bleeding tendency disorders,
• Future fertility concerns,
• Class II obesity or greater (BMI \> 35)
• Subject has any other disease or condition(s) that would interfere with completion of the study and follow-up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes,
• Concomitant participation in another interventional study.

Sponsors & Collaborators

• Andromeda Surgical: lead

Study Sites (5)

The Hill Clinic

Sofia, 1616, Bulgaria

RECRUITING

Clinica Universidad Católica

Santiago, 8320165, Chile

RECRUITING

Hospital Clínico Universidad de Chile

Santiago, 8380456, Chile

RECRUITING

Canterbury Urology Research Trust

Christchurch, 8013, New Zealand

RECRUITING

Tauranga Urology Research Ltd

Tauranga, 3140, New Zealand

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: September 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

BU (1); CL (2); NZ (2)