A 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
This single-arm study aims to evaluate the Beacon Platform, an advancement in urological surgery. The study will assess its intraoperative and postoperative outcomes. The aim of this investigation is to establish safety and performance of the Beacon Platform.
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 diagnosed 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
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov