Beacon robotic platform to assist Holmium Laser Enucleation of the Prostate (HoLEP)

A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)

This tests whether the Beacon robotic platform helps surgeons perform HoLEP for men with benign prostatic enlargement who have urinary symptoms or retention.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 45 Years and up
• Sex: Male
• Sponsor: Andromeda Surgical (industry)
• Locations: 3 sites (Santiago, Santiago Metropolitan and 2 other locations)
• Trial ID: NCT06668142 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, multicenter pilot using the Beacon Platform during HoLEP procedures to observe intraoperative performance and postoperative outcomes. Men aged 45 or older with symptomatic benign prostatic enlargement and prostate volumes between 40 and 120 cc who are indicated for HoLEP are eligible. Participating sites in Chile and New Zealand will collect perioperative metrics, surgical times, complications, and early functional outcomes after the robotic-assisted procedure. The study focuses on feasibility and safety and does not include a randomized control arm.

Who should consider this trial

Good fit: Ideal candidates are men aged 45 or older with lower urinary tract symptoms or urinary retention from benign prostatic enlargement, prostate volume 40–120 cc, who are scheduled for HoLEP and can give informed consent.

Not a fit: Patients with current or suspected prostate or bladder cancer, active urethral stricture or bladder neck contracture, or prostates outside the 40–120 cc range, and those not eligible for HoLEP, are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the platform could improve surgical precision and consistency for HoLEP, potentially reducing complications and shortening recovery.

How similar studies have performed: Robotic or semi-robotic approaches to HoLEP (often called RoLEP) have appeared in small feasibility series with promising perioperative results, but larger controlled trials are still lacking.

Eligibility criteria

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 40 - 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within one year 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 current/suspected 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),
10. Any severe illness that would prevent complete study participation or confound study results.
11. Bleeding tendency disorders,
12. Future fertility concerns,
13. 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,
14. Concomitant participation in another interventional study

Where this trial is running

Santiago, Santiago Metropolitan and 2 other locations

• Universidad Catolica de Chile — Santiago, Santiago Metropolitan, Chile (RECRUITING)
• Hospital Clínico de la Universidad de Chile — Santiago, Santiago Metropolitan, Chile (RECRUITING)
• Tauranga Urology Research Limited — Tauranga, New Zealand (RECRUITING)

Study contacts

• Principal investigator: Peter Gilling, MD, FRACS — Tauranga urology research
• Study coordinator: Rami Abukhalil, MD. MPH

Conditions: Benign Prostatic Hyperplasia, HoLEP, RoLEP, Robotic HoLEP, BPH, Prostate, urology, robotic