Health TrialsbyHealthPanel

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

ConditionsBPH (Benign Prostatic Hyperplasia)HoLEP (Holmium Laser Enucleation of Prostate)
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Beacon Platform

    Device

    Procedure is performed using the Beacon Platform

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Procedure performed with Beacon PlatformExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Successful completion of the enucleation phase of HoLEP with the Beacon Platform

Successful completion of the enucleation phase of HoLEP without the need to convert to conventional (non-robot-assisted) HoLEP, or an alternative surgical procedure for treatment of BPH-related LUTS. This excludes the use of other devices for hemostasis or dissecting the enucleated tissue during or after the procedure and cases identified by the urologist that require conversion to a non-HoLEP procedure due to factors unrelated to the device performance.

Time frame
Perioperative
2

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.

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. The key landmarks included: * Verumontanum * External Sphincter * Apical plane (between sphincter \& adenoma) * Lobes of the prostate * Bladder neck * Bilateral ureteric orifices * The lateral, posterior, and anterior bladder walls. Success is defined as the Beacon Platform achieving clear visualization and scope proximity to all landmarks deemed non-inferior to standard non-robotic rigid cystoscopy as judged by the operating surgeon using a Likert scale assessment tool at the time of the procedure. Failure is defined as inability to visualize/access any landmark due to technical factors.

Time frame
Perioperative
3

Rate of procedure related adverse events (AEs)

Proportion of subjects with adverse events rated as probably or definitely related to the study procedure (robot-assisted HoLEP or RoLEP) classified as Clavien-Dindo Grade 3a or higher through 30 days post-treatment.

Time frame
Through study completion, an average of 30 days

Secondary outcomes

1

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
2

Incidence of ureteric orifice damage leading to stricture, stenting of the ureter, or other sequelae or subsequent intervention

Time frame
30 days
3

Duration of hospital stay following the procedure

Time frame
30 days
4

Duration of catheterization following the procedure

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Andromeda Surgical

Lead sponsor

Source ClinicalTrials.gov
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