Benign Prostatic HyperplasiaNCT06668142
A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
A study testing Beacon Platform in people with Benign Prostatic Hyperplasia, run by Andromeda Surgical at 3 sites in 2 countries.
Trial summary
Robotic assisted surgery for benign prostatic hyperplasia (BPH) Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- 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
- 54 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 12 Dec 2024to 30 Dec 2026
- 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 40 - 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within one year 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 current/suspected 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),
- Any severe illness that would prevent complete study participation or confound study results.
- Bleeding tendency disorders,
- Future fertility concerns,
- 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
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Michael Nketiah contact
3 sites in 2 countries
Chile2 sites, 2 recruiting
- Recruiting
Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 8320165
Cristian Trucco Brito, +56992341965, ctrucco@ucchristus.cl
Gaston Astroza
- Recruiting
Hospital Clínico de la Universidad de Chile
Santiago, Santiago Metropolitan, 8380453
Rodrigo Ledezma, +56977593793, rodrigoledezma@gmail.com
Rodrigo Ledezma
New Zealand1 site, 1 recruiting
- Recruiting
Tauranga Urology Research Limited
Tauranga
Margaret Ross, 64 (7) 577 77 95, marg@urobop.co.nz
About this study
Robotic assisted surgery for benign prostatic hyperplasia (BPH)
Read the detailed description
A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Beacon Platform
- Keywords
- HoLEP, RoLEP, Robotic HoLEP, BPH, Prostate, urology, robotic, Andromeda, ASTRA
- 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
The Beacon Platform is a robotically assisted surgical (RAS) device. It enables the urologist, through software, to control and move surgical instruments for a variety of transurethral, endoscopic procedures
| Study group | Role | What they receive |
|---|---|---|
| A single-arm open label pilot study | Experimental | A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP. Receives: Device: Beacon Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Successfully Completing Robot-Assisted HoLEP (Enucleation and Morcellation) Without Conversion
This endpoint measures the number of participants who successfully complete both the enucleation and morcellation phases of robot-assisted HoLEP (Holmium Laser Enucleation of the Prostate) without the need to convert to a conventional HoLEP or an alternative surgical procedure for treating BPH-related LUTS.Successful completion is defined as completing both phases without using additional devices .
This excludes the Roll-in subjects and the use of other devices for hemostasis or dissecting the enucleated tissue during or after the procedure.
Measured: During the procedure.
Number of subjects with adverse events ( Clavien-Dindo Grade 3a or higher )
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: From procedure date to 30 days
Secondary outcomes (7)
Number of Participants with Capsular Perforation Leading to Procedure Interruption or Conversion
This outcome measures the incidence of capsular perforation events that result in interruption of the procedure or conversion to conventional HoLEP or an alternative surgical procedure
Measured: From procedure date to 30 days.
Number of Participants with Bladder Perforation Leading to Procedure Interruption or Conversion
This outcome measures the incidence of bladder perforation events that result in interruption of the procedure or conversion to conventional HoLEP or an alternative surgical procedure.
Measured: From procedure date to 30 days.
Number of Participants with Ureteric Orifice Damage Requiring Intervention
This outcome assesses the incidence of ureteric orifice damage leading to stricture, stenting, or any other sequelae or subsequent intervention.
Measured: From procedure date to 30 days.
Length of Hospital Stay Post-Procedure
This outcome measures the total length of hospital stay required following the HoLEP procedure.
Measured: From procedure date to 30 days
Length of Catheterization Post-Procedure
This outcome measures the total duration of catheterization following the procedure.
Measured: From procedure date to 30 days
Operative Time for Procedure Completion
This outcome measures the total time required to complete the HoLEP procedure.
Measured: During the procedure.
Number of Participants with Repeat Hospitalization for Genitourinary Conditions
This outcome measures the incidence of repeat hospitalizations due to genitourinary conditions within 30 days post-procedure.
Measured: From procedure date to 30 days post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start12 Dec 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andromeda Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Gilling, MD, FRACS, Principal investigator, Tauranga urology researchRodrigo Ledezma, MD,, Principal investigator, University of Chile Clinical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668142
- Sponsor's protocol ID
- ASTRA112024
- Status last verified
- Mar 2026
- First submitted
- 23 Oct 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shvero A, Kloniecke E, Capella C, Das AK. HoLEP techniques - lessons learned. Can J Urol. 2021 Aug;28(S2):11-16.
PubMed 34453423Abedi A, Razzaghi MR, Rahavian A, Hazrati E, Aliakbari F, Vahedisoraki V, Allameh F. Is Holmium Laser Enucleation of the Prostate a Good Surgical Alternative in Benign Prostatic Hyperplasia Management? A Review Article. J Lasers Med Sci. 2020 Spring;11(2):197-203. doi: 10.34172/jlms.2020.33. Epub 2020 Mar 15.
PubMed 32273963Das AK, Han TM, Hardacker TJ. Holmium laser enucleation of the prostate (HoLEP): size-independent gold standard for surgical management of benign prostatic hyperplasia. Can J Urol. 2020 Aug;27(S3):44-50.
PubMed 32876002Das AK, Teplitsky S, Humphreys MR. Holmium laser enucleation of the prostate (HoLEP): a review and update. Can J Urol. 2019 Aug;26(4 Suppl 1):13-19.
PubMed 31481144
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
- ClinicalTrials.gov ID
- NCT06668142
- Acronym / sponsor ID
- ASTRA112024
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- HoLEP, RoLEP, Robotic HoLEP, BPH, Prostate, urology, robotic, Andromeda
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Andromeda SurgicalIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 31 Oct 2024 (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.
Robotic assisted surgery for benign prostatic hyperplasia (BPH)
Detailed description
A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single-arm open label pilot study | Experimental | Device: Beacon PlatformA single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP. |
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 (14 listed)
- Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,
- History of prostate cancer or current/suspected 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 PlatformThe Beacon Platform is a robotically assisted surgical (RAS) device. It enables the urologist, through software, to control and move surgical instruments for a variety of transurethral, endoscopic procedures | Device | A single-arm open label pilot study |
Primary outcome
Number of Participants Successfully Completing Robot-Assisted HoLEP (Enucleation and Morcellation) Without Conversion
Time frame: During the procedure.
This endpoint measures the number of participants who successfully complete both the enucleation and morcellation phases of robot-assisted HoLEP (Holmium Laser Enucleation of the Prostate) without the need to convert to a conventional HoLEP or an alternative surgical procedure for treating BPH-related LUTS.Successful completion is defined as completing both phases without using additional devices . This excludes the Roll-in subjects and the use of other devices for hemostasis or dissecting the enucleated tissue during or after the procedure.
Number of subjects with adverse events ( Clavien-Dindo Grade 3a or higher )
Time frame: From procedure date to 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.
7 secondary outcomes
Number of Participants with Capsular Perforation Leading to Procedure Interruption or Conversion
Time frame: From procedure date to 30 days.
Number of Participants with Bladder Perforation Leading to Procedure Interruption or Conversion
Time frame: From procedure date to 30 days.
Number of Participants with Ureteric Orifice Damage Requiring Intervention
Time frame: From procedure date to 30 days.
Length of Hospital Stay Post-Procedure
Time frame: From procedure date to 30 days
Length of Catheterization Post-Procedure
Time frame: From procedure date to 30 days
Operative Time for Procedure Completion
Time frame: During the procedure.
Number of Participants with Repeat Hospitalization for Genitourinary Conditions
Time frame: From procedure date to 30 days post-procedure.
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 23 Mar 2026.
- Background: PubMed 34453423Shvero A, Kloniecke E, Capella C, Das AK. HoLEP techniques - lessons learned. Can J Urol. 2021 Aug;28(S2):11-16.
- Background: PubMed 32273963Abedi A, Razzaghi MR, Rahavian A, Hazrati E, Aliakbari F, Vahedisoraki V, Allameh F. Is Holmium Laser Enucleation of the Prostate a Good Surgical Alternative in Benign Prostatic Hyperplasia Management? A Review Article. J Lasers Med Sci. 2020 Spring;11(2):197-203. doi: 10.34172/jlms.2020.33. Epub 2020 Mar 15.
- Background: PubMed 32876002Das AK, Han TM, Hardacker TJ. Holmium laser enucleation of the prostate (HoLEP): size-independent gold standard for surgical management of benign prostatic hyperplasia. Can J Urol. 2020 Aug;27(S3):44-50.
- Background: PubMed 31481144Das AK, Teplitsky S, Humphreys MR. Holmium laser enucleation of the prostate (HoLEP): a review and update. Can J Urol. 2019 Aug;26(4 Suppl 1):13-19.
- Individual participant dataSharing planned: No
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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.
Michael Nketiah contact
Peter Gilling, MD, FRACS principal investigator
Tauranga urology research
Rodrigo Ledezma, MD, principal investigator
University of Chile Clinical Hospital
3 sites in 2 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 Benign Prostatic Hyperplasia, run by Andromeda Surgical at 3 sites in 2 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 14 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 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Chile, New Zealand. 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?
Contact Rami Abukhalil, MD. MPH (513-808-2097, rami@andromedasurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Successfully Completing Robot-Assisted HoLEP (Enucleation and Morcellation) Without Conversion (time frame: During the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06668142, which also lists 4 linked publications.
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 23 Mar 2026.