HoLEP techniques - lessons learned.
Asaf Shvero, Edward Kloniecke, Courtney Capella...
https://pubmed.ncbi.nlm.nih.gov/34453423Actively Recruiting
Phase Not Applicable
Age: 45Years +
MALE
ID06668142
Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP) in Men with Benign Prostatic Hyperplasia
Led by Andromeda Surgical · Updated on 2026-03-23
54
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the Beacon Platform, a robotically assisted surgical device, for treating benign prostatic hyperplasia (BPH) in men. The study focuses on observing the outcomes of the Holmium Laser Enucleation of the Prostate (HoLEP) procedure using this platform. It is a prospective, multicenter, open-label pilot study designed to gather information on both intraoperative and postoperative results. Participants will undergo the HoLEP procedure assisted by the Beacon Platform, which allows the urologist to control surgical instruments through software during transurethral, endoscopic surgery. This single-arm study monitors the procedure without comparing to other treatments. The study tracks outcomes such as successful completion of the robot-assisted surgery without conversion and adverse events occurring up to 30 days after the procedure. During the study, participants will be closely monitored for safety and effectiveness through various assessments, including length of hospital stay, catheterization duration, operative time, and any complications such as perforations or damage requiring intervention. Researchers will also observe hospital readmissions related to genitourinary conditions within 30 days following the surgery. Participant involvement includes signing informed consent, undergoing the procedure, and completing follow-up evaluations until the study concludes.
CONDITIONS
Brief Title
A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
Who Can Participate
Age: 45Years +
MALE
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
- Age 45 years or older
- Prostate volume between 40 and 120 cc by ultrasound, MRI, or CT within one year prior to procedure
- Indicated for HoLEP procedure
You will not qualify if you...
- Current or recurrent urethral stricture, meatal stenosis, or bladder neck contracture
- History of prostate cancer or current/suspected bladder cancer
- Prostate cancer not ruled out if PSA is above acceptable thresholds
- Other diseases causing voiding dysfunction such as neurogenic bladder, Parkinson's disease, or multiple sclerosis
- Overactive bladder without benign prostatic obstruction
- Acute urinary tract infection or asymptomatic bacteriuria unless treated
- Previous pelvic irradiation or radical pelvic surgery
- Previous prostate surgery including enucleation, resection, vaporization, thermotherapy, ablation, stenting, or prostatic urethral lift
- Unable to stop anticoagulants or antiplatelets as required before procedure
- Severe illness preventing study participation or confounding results
- Bleeding tendency disorders
- Future fertility concerns
- Any condition interfering with study completion or increasing risks
- Participation in another interventional study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Procedure day and hospital stay up to 30 days
Participants undergo the robotically assisted Holmium Laser Enucleation of the Prostate (HoLEP) using the Beacon Platform and receive immediate post-operative care.
1 surgical visit and post-operative hospital stay
Post-operative Follow-up
Duration - Up to 30 days post-procedure
Participants are monitored for recovery, adverse events, catheterization duration, and any hospital readmissions related to the procedure.
Follow-up visits during 30 days post-procedure
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
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Research Team
R
Rami Abukhalil, MD. MPH
M
Michael Nketiah
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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Published Research Related To This Trial
Is Holmium Laser Enucleation of the Prostate a Good Surgical Alternative in Benign Prostatic Hyperplasia Management? A Review Article.
Amirreza Abedi, Mohammad Reza Razzaghi, Amirhossein Rahavian...
https://pubmed.ncbi.nlm.nih.gov/32273963Holmium laser enucleation of the prostate (HoLEP): size-independent gold standard for surgical management of benign prostatic hyperplasia.
Akhil K Das, Timothy M Han, Thomas J Hardacker
https://pubmed.ncbi.nlm.nih.gov/32876002Holmium laser enucleation of the prostate (HoLEP): a review and update.
Akhil K Das, Seth Teplitsky, Mitchell R Humphreys
https://pubmed.ncbi.nlm.nih.gov/31481144