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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45+
SponsorAndromeda Surgical

About this trial

Robotic assisted surgery for benign prostatic hyperplasia (BPH)

Eligibility criteria

Qualifiers

Male

Subject has diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction,

Subject is able and willing to comply with all the assessments of the study,

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,

Disqualifiers

Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,

History of prostate cancer or current/suspected bladder cancer,

Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds,

History of other diseases causing voiding dysfunction including urinary retention (e.g., diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),

Trial design

Treatments tested in this trial

  • Beacon Platform

Treatment groups

54 Participants
are divided into 1 treatment group

Locations

3
Chile
Hospital Clínico de la Universidad de Chile8380453, SantiagoSantiago Metropolitan, Chile
Universidad Catolica de Chile8320165, SantiagoSantiago Metropolitan, Chile
New Zealand
Tauranga Urology Research Limited Tauranga New Zealand

Sponsors and collaborators

Andromeda Surgical

Lead sponsor