A Pilot, Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 5
- Primary Endpoint
- Successful completion of the enucleation phase of HoLEP with the Beacon Platform
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Outcomes
Primary Outcomes
Successful completion of the enucleation phase of HoLEP with the Beacon Platform
Time Frame: Perioperative
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.
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
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.
Rate of procedure related adverse events (AEs)
Time Frame: Through study completion, an average of 30 days
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.
Secondary Outcomes
- Incidence of bladder perforation or capsular perforation leading to interruption of the procedure or conversion to conventional HoLEP or other alternative procedure(Perioperative)
- Incidence of ureteric orifice damage leading to stricture, stenting of the ureter, or other sequelae or subsequent intervention(30 days)
- Duration of hospital stay following the procedure(30 days)
- Duration of catheterization following the procedure(30 days)
- Total enucleation time(Perioperative)
- Incidence of repeat hospitalization for genitourinary conditions within 30 days post procedure(30 days)