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RecruitingNCT06668142Updated Mar 23, 2026

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

An interventional study of Beacon Platform in Benign Prostatic Hyperplasia, sponsored by Andromeda Surgical. Recruiting at 3 sites in 2 countries. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Andromeda Surgical · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
45 Years and older
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Benign Prostatic Hyperplasia

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Keywords

  • HoLEP
  • RoLEP
  • Robotic HoLEP
  • BPH
  • Prostate
  • urology
  • robotic
  • Andromeda
  • ASTRA
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's planned enrollment of 54 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Andromeda Surgical is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. Male
  2. Subject has diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction,
  3. Subject is able and willing to comply with all the assessments of the study,
  4. 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,
  5. ≥ 45 years of Age,
  6. Prostate volume 40 - 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within one year prior to procedure,
  7. The subject is indicated for undergoing HoLEP procedure

Exclusion criteria

Exclusion Criteria:

  1. Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,
  2. History of prostate cancer or current/suspected bladder cancer,
  3. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds,
  4. History of other diseases causing voiding dysfunction including urinary retention (e.g., diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
  5. Subjects with overactive bladder in the absence of benign prostatic obstruction as determined by the investigator,
  6. Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated)
  7. Previous pelvic irradiation or radical pelvic surgery,
  8. Previous prostate surgery, including enucleation, resection, vaporization, thermotherapy, ablation, stenting, or prostatic urethral lift,
  9. 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),
  10. Any severe illness that would prevent complete study participation or confound study results.
  11. Bleeding tendency disorders,
  12. Future fertility concerns,
  13. 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,
  14. Concomitant participation in another interventional study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    A single-arm open label pilot study

    A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP.

    Device: Beacon Platform

Interventions

  • DeviceBeacon Platform

    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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: During the procedure.

  2. 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.

    Time frame: From procedure date to 30 days

Secondary outcomes

  1. 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

    Time frame: From procedure date to 30 days.

  2. 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.

    Time frame: From procedure date to 30 days.

  3. 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.

    Time frame: From procedure date to 30 days.

  4. Length of Hospital Stay Post-Procedure

    This outcome measures the total length of hospital stay required following the HoLEP procedure.

    Time frame: From procedure date to 30 days

  5. Length of Catheterization Post-Procedure

    This outcome measures the total duration of catheterization following the procedure.

    Time frame: From procedure date to 30 days

  6. Operative Time for Procedure Completion

    This outcome measures the total time required to complete the HoLEP procedure.

    Time frame: During the procedure.

  7. 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.

    Time frame: From procedure date to 30 days post-procedure.

Other outcomes

  1. Duration of Enucleation and Morcellation Phases

    This outcome measures the combined time taken to complete the enucleation and morcellation phases of the HoLEP procedure.

    Time frame: During the procedure.

  2. Number of Participants Requiring Blood Transfusion Post-Procedure

    This outcome tracks the incidence of blood transfusion events following the HoLEP procedure.

    Time frame: From procedure date to 30 days.

  3. Number of Participants Requiring Secondary Reintervention with HoLEP or Alternative Surgical Therapy

    This outcome measures the incidence of participants requiring a secondary reintervention using HoLEP or an alternative surgical therapy for LUTS within 30 days post-procedure.

    Time frame: From procedure date to 30 days.

  4. Incidence Rate of Stress Urinary Incontinence Post-Procedure

    This outcome assesses the rate of stress urinary incontinence among participants within 30 days following the procedure.

    Time frame: From procedure date to 30 days.

07

Study locations

3 of 3 sites recruiting
  • Universidad Catolica de Chile
    Santiago, Santiago Metropolitan 8320165, Chile
    • Cristian Trucco Brito · Contact · ctrucco@ucchristus.cl · +56992341965
    • Gaston Astroza · Contact
    • Cristian Trucco Brito · Principal investigator
    Recruiting
  • Hospital Clínico de la Universidad de Chile
    Santiago, Santiago Metropolitan 8380453, Chile
    Recruiting
  • Tauranga Urology Research Limited
    Tauranga, New Zealand
    Recruiting
08

References and documents

Publications

  • Shvero A, Kloniecke E, Capella C, Das AK. HoLEP techniques - lessons learned. Can J Urol. 2021 Aug;28(S2):11-16. PubMed 34453423 ↗
  • Abedi 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 32273963 ↗
  • Das 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 32876002 ↗
  • Das 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06668142
Lead sponsor
Andromeda Surgical
Responsible party
Sponsor
First posted
Oct 31, 2024
Start date
Dec 12, 2024
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Mar 23, 2026

Study contacts

Rami Abukhalil, MD. MPH
Contact
rami@andromedasurgical.com
513-808-2097
Michael Nketiah
Contact
Peter Gilling, MD, FRACS
principal investigator · Tauranga urology research
Rodrigo Ledezma, MD,
principal investigator · University of Chile Clinical Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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