What is the Beacon Platform studying for benign prostatic hyperplasia?

The Beacon Platform is being studied to see how it helps perform Holmium Laser Enucleation of the Prostate (HoLEP) surgery for benign prostatic hyperplasia. Researchers want to understand the outcomes during and after this robot-assisted procedure. The study is sponsored by Andromeda Surgical to gather important safety and performance data.

Who may be eligible for this benign prostatic hyperplasia clinical trial?

Men aged 45 years or older with lower urinary tract symptoms or urinary retention due to benign prostatic enlargement may be eligible. Participants must have a prostate volume between 40 and 120 cc and be suitable for the HoLEP procedure. Certain health conditions and previous prostate surgeries may exclude participants. Please review eligibility criteria for more details.

Is there any cost to participate in this benign prostatic hyperplasia clinical trial?

Study-related care, including the use of the Beacon Platform and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants can plan accordingly for any additional costs beyond the study procedures.

Actively Recruiting

Phase Not Applicable

Age: 45Years +

MALE

ID06668142

Study of the Beacon Robot-Assisted Platform for Holmium Laser Surgery in Men with Benign Prostatic Enlargement

Led by Andromeda Surgical · Updated on 2026-03-23

Participants Needed

Research Sites

N/A

Total Duration

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

Research Team

Rami Abukhalil, MD. MPH

Michael Nketiah

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