BPH (Benign Prostatic Hyperplasia)NCT07741656
A Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
A study testing Beacon Platform in people with BPH (Benign Prostatic Hyperplasia) and HoLEP (Holmium Laser Enucleation of Prostate), run by Andromeda Surgical at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia), HoLEP (Holmium Laser Enucleation of Prostate)
- What is being tested?
- Beacon Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 26 Sep 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
Chile2 sites, 2 recruiting
- Recruiting
Clinica Universidad Católica
Santiago, 8320165
CRO, +569 95163080, contact@bopalcro.com
Cristián Trucco
- Recruiting
Hospital Clínico Universidad de Chile
Santiago, 8380456
CRO, +569 95163080, contact@bopalcro.com
Rodrigo Ledezma
New Zealand2 sites, 2 recruiting
- Recruiting
Canterbury Urology Research Trust
Christchurch, 8013
Study Coordinator, +64 (3) 35 52 426, liz@medicaltrials.co.nz
Giovanni Losco
- Recruiting
Tauranga Urology Research Ltd
Tauranga, 3140
Research Nurse Manager, +64 (7) 577 77 95, marg@urobop.co.nz
Peter Gilling, Prof
Bulgaria1 site, 1 recruiting
- Recruiting
The Hill Clinic
Sofia, 1616
CRO, +359 2 439 3131, contact@hillclinic.com
Georgi Georgiev
About this study
Official title: A Pilot, Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
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.
- Being tested
- Beacon Platform
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beacon PlatformDevice
Procedure is performed using the Beacon Platform
| Study group | Role | What they receive |
|---|---|---|
| Procedure performed with Beacon Platform | Experimental | All participants will undergo the procedure with the Beacon Platform Receives: Device: Beacon Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: Perioperative
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.
Measured: Through study completion, an average of 30 days
Secondary outcomes (6)
Incidence of bladder perforation or capsular perforation leading to interruption of the procedure or conversion to conventional HoLEP or other alternative procedure
Measured: Perioperative
Incidence of ureteric orifice damage leading to stricture, stenting of the ureter, or other sequelae or subsequent intervention
Measured: 30 days
Duration of hospital stay following the procedure
Measured: 30 days
Duration of catheterization following the procedure
Measured: 30 days
Total enucleation time
Measured: Perioperative
Incidence of repeat hospitalization for genitourinary conditions within 30 days post procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start26 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andromeda Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741656
- Sponsor's protocol ID
- ASTRA 2
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
- ClinicalTrials.gov ID
- NCT07741656
- Acronym / sponsor ID
- ASTRA 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Andromeda SurgicalIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedure performed with Beacon Platform | Experimental | Device: Beacon PlatformAll participants will undergo the procedure with the Beacon Platform |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beacon PlatformProcedure is performed using the Beacon Platform | Device | Procedure performed with Beacon Platform |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beacon Platform in people with BPH (Benign Prostatic Hyperplasia) and HoLEP (Holmium Laser Enucleation of Prostate), run by Andromeda Surgical at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Chile, New Zealand, Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful completion of the enucleation phase of HoLEP with the Beacon Platform (time frame: Perioperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.