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

Robotic assisted surgery for benign prostatic hyperplasia (BPH)

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: Beacon Platform

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rami Abukhalil, MD. MPH; Phone Number: 513-808-2097; Email: rami@andromedasurgical.com
• Study Contact Backup: Name: Michael Nketiah

Study Locations

• Chile
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile, 8320165
      • Recruiting
      • Universidad Catolica de Chile
      • Contact: Cristian Trucco Brito; Phone Number: +56992341965; Email: ctrucco@ucchristus.cl
      • Contact: Gaston Astroza
      • Principal Investigator: Cristian Trucco Brito
    • Santiago, Santiago Metropolitan, Chile, 8380453
      • Recruiting
      • Hospital Clinico de la Universidad de Chile
      • Contact: Rodrigo Ledezma; Phone Number: +56977593793; Email: rodrigoledezma@gmail.com
      • Principal Investigator: Rodrigo Ledezma
• New Zealand
  • Tauranga, New Zealand
    • Recruiting
    • Tauranga Urology Research Limited
    • Contact: Margaret Ross; Phone Number: 64 (7) 577 77 95; Email: marg@urobop.co.nz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From procedure date to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	From procedure date to 30 days
Length of Catheterization Post-Procedure	This outcome measures the total duration of catheterization following the procedure.	From procedure date to 30 days
Operative Time for Procedure Completion	This outcome measures the total time required to complete the HoLEP procedure.	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.	From procedure date to 30 days post-procedure.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Enucleation and Morcellation Phases	This outcome measures the combined time taken to complete the enucleation and morcellation phases of the HoLEP procedure.	During the procedure.
Number of Participants Requiring Blood Transfusion Post-Procedure	This outcome tracks the incidence of blood transfusion events following the HoLEP procedure.	From procedure date to 30 days.
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.	From procedure date to 30 days.
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.	From procedure date to 30 days.

Collaborators and Investigators

• Sponsor: Andromeda Surgical
• Investigators: Principal Investigator: Peter Gilling, MD, FRACS, Tauranga urology research; Principal Investigator: Rodrigo Ledezma, MD,, University of Chile Clinical Hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Prostate; robotic; BPH; HoLEP; urology; RoLEP; Robotic HoLEP; Andromeda; ASTRA
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: ASTRA112024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No