Beacon Platform for HoLEP: Safer, Smarter Prostate Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm study evaluates the Beacon Platform in the context of Holmium Laser Enucleation of the Prostate (HoLEP). It looks at intraoperative performance and postoperative safety to determine if the platform can support effective, safe surgery for men with benign prostatic enlargement. Participants are men aged 45 and older with specific prostate size criteria who are scheduled for HoLEP. The study is sponsored by Andromeda Surgical and is conducted at sites in Sofia and Santiago. No comparator group is used in this evaluation, and outcomes focus on feasibility and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male
2. Subject has diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction,
3. Subject is able and willing to comply with all the assessments of the study,
4. 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,
5. ≥ 45 years of Age,
6. 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,
7. The subject is indicated for undergoing HoLEP procedure

Exclusion Criteria:

1. Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,
2. History of prostate cancer or diagnosed bladder cancer
3. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds,
4. History of other diseases causing voiding dysfunction including urinary retention (e.g., diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
5. Subjects with overactive bladder in the absence of benign prostatic obstruction as determined by the investigator,
6. Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated)
7. Previous pelvic irradiation or radical pelvic surgery,
8. Previous prostate surgery, including enucleation, resection, vaporization, thermotherapy, ablation, stenting, or prostatic urethral lift,
9. 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
10. Any severe illness that would prevent complete study participation or confound study results.
11. Bleeding tendency disorders,
12. Future fertility concerns,
13. Class II obesity or greater (BMI \> 35)
14. 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,
15. Concomitant participation in another interventional study.

Where it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.