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Recruiting NCT07741656

A Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)

No phase Interventional BPH (Benign Prostatic Hyperplasia) HoLEP (Holmium Laser Enucleation of Prostate)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Beacon Platform.
Who it may be relevant to
Registry conditions: BPH (Benign Prostatic Hyperplasia), HoLEP (Holmium Laser Enucleation of Prostate). Basic parameters: from 45 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Bulgaria, Chile, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Beacon Platform
    Procedure is performed using the Beacon Platform

Primary outcome measures

  • Successful completion of the enucleation phase of HoLEP with the Beacon Platform [Time frame: Perioperative]
  • The rate of successful endoscopic access to and visualization of the predefined anatomical landmarks in the urinary tract in a non-inferior fashion compared to standard rigid diagnostic cystoscopy. [Time frame: Perioperative]
  • Rate of procedure related adverse events (AEs) [Time frame: Through study completion, an average of 30 days]
Secondary outcome measures (6)
  • Incidence of bladder perforation or capsular perforation leading to interruption of the procedure or conversion to conventional HoLEP or other alternative procedure [Time frame: Perioperative]
  • Incidence of ureteric orifice damage leading to stricture, stenting of the ureter, or other sequelae or subsequent intervention [Time frame: 30 days]
  • Duration of hospital stay following the procedure [Time frame: 30 days]
  • Duration of catheterization following the procedure [Time frame: 30 days]
  • Total enucleation time [Time frame: Perioperative]
  • Incidence of repeat hospitalization for genitourinary conditions within 30 days post procedure [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • 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,
  • ≥ 45 years of Age,
  • Prostate volume 30 cc to 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within 180 days prior to procedure,
  • The subject is indicated for undergoing HoLEP procedure

Exclusion criteria

  • 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.),
  • Subjects with overactive bladder in the absence of benign prostatic obstruction as determined by the investigator,
  • Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is 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 taking anticoagulants for at least 3 days prior to the procedure or antiplatelets and/or coumadin for at least 5 days prior to the procedure (Note: low dose aspirin therapy is permitted), bridging anticoagulation therapy is permitted if managed per institutional guidelines and does not increase perioperative bleeding risk
  • Any severe illness that would prevent complete study participation or confound study results.
  • Bleeding tendency disorders,
  • Future fertility concerns,
  • Class II obesity or greater (BMI > 35)
  • Subject has any other disease or condition(s) that would interfere with completion of the study and follow-up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes,
  • Concomitant participation in another interventional study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Chile · 2 centers
  • Clinica Universidad Católica — Santiago
  • Hospital Clínico Universidad de Chile — Santiago
New Zealand · 2 centers
  • Canterbury Urology Research Trust — Christchurch
  • Tauranga Urology Research Ltd — Tauranga
Bulgaria · 1 center
  • The Hill Clinic — Sofia

Identifiers

NCT: NCT07741656 · ASTRA 2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗