Actively Recruiting
A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
Led by Andromeda Surgical · Updated on 2026-03-23
54
Participants Needed
3
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Robotic assisted surgery for benign prostatic hyperplasia (BPH)
CONDITIONS
Official Title
A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male
- Diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction
- Able and willing to comply with all study assessments
- Provided informed consent to participate
- Age 45 years or older
- Prostate volume between 40 and 120 cc measured by ultrasound, MRI, or CT within one year prior to procedure
- Indicated for undergoing HoLEP procedure
You will not qualify if you...
- Urethral stricture, meatal stenosis, or bladder neck contracture (current or recurrent)
- History of prostate cancer or current/suspected bladder cancer
- Prostate cancer must be ruled out if PSA is above acceptable thresholds
- History of diseases causing voiding dysfunction such as neurogenic bladder, Parkinson's disease, multiple sclerosis
- Overactive bladder without benign prostatic obstruction
- Acute urinary tract infection or asymptomatic bacteriuria (enrollment possible if UTI 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 anticoagulants or antiplatelets as required before procedure (low dose aspirin allowed)
- Severe illness preventing study participation or confounding results
- Bleeding tendency disorders
- Future fertility concerns
- Any condition interfering with study completion or increasing procedure risks
- Participation in another interventional study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Universidad Catolica de Chile
Santiago, Santiago Metropolitan, Chile, 8320165
Actively Recruiting
2
Hospital Clínico de la Universidad de Chile
Santiago, Santiago Metropolitan, Chile, 8380453
Actively Recruiting
3
Tauranga Urology Research Limited
Tauranga, New Zealand
Actively Recruiting
Research Team
R
Rami Abukhalil, MD. MPH
CONTACT
M
Michael Nketiah
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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