NCT06668142 A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
| NCT ID | NCT06668142 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Andromeda Surgical |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2024-12-12 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Robotic assisted surgery for benign prostatic hyperplasia (BPH)
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
Contact & Investigator
Peter Gilling, MD, FRACS
PRINCIPAL INVESTIGATOR
Tauranga urology research
Frequently Asked Questions
Who can join the NCT06668142 clinical trial?
This trial is open to male participants only, aged 45 Years or older, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06668142 currently recruiting?
Yes, NCT06668142 is actively recruiting participants. Contact the research team at rami@andromedasurgical.com for enrollment information.
Where is the NCT06668142 trial being conducted?
This trial is being conducted at Santiago, Chile, Santiago, Chile, Tauranga, New Zealand.
Who is sponsoring the NCT06668142 clinical trial?
NCT06668142 is sponsored by Andromeda Surgical. The principal investigator is Peter Gilling, MD, FRACS at Tauranga urology research. The trial plans to enroll 54 participants.