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

Recruiting now · Not applicable

Conditions studied: BPH (Benign Prostatic Hyperplasia), HoLEP (Holmium Laser Enucleation of Prostate)

In brief

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.

Key facts

Study ID

NCT07741656

Run by

Andromeda Surgical

People needed

50

Starts

2025-09-26

Expected to finish

2027-01-31

Last updated by the study team

2026-08-03

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

• The Hill Clinic — Sofia, Bulgaria (enrolling)
• Clinica Universidad Católica — Santiago, Chile (enrolling)
• Hospital Clínico Universidad de Chile — Santiago, Chile (enrolling)
• Canterbury Urology Research Trust — Christchurch, New Zealand (enrolling)
• Tauranga Urology Research Ltd — Tauranga, New Zealand (enrolling)

Full record on ClinicalTrials.gov

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