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

NCT06668142 | Recruiting

• 1 other identifier: ASTRA112024
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 3

Brief Summary

Robotic assisted surgery for benign prostatic hyperplasia (BPH)

Conditions

Benign Prostatic Hyperplasia

Keywords

HoLEP; RoLEP; Robotic HoLEP; BPH; Prostate; urology; robotic; Andromeda; ASTRA

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Number of Participants with Capsular Perforation Leading to Procedure Interruption or Conversion

  From procedure date to 30 days.

• Number of Participants with Bladder Perforation Leading to Procedure Interruption or Conversion

  From procedure date to 30 days.

• Number of Participants with Ureteric Orifice Damage Requiring Intervention

  From procedure date to 30 days.

• Length of Hospital Stay Post-Procedure

  From procedure date to 30 days

• Length of Catheterization Post-Procedure

  From procedure date to 30 days

Other Outcomes (4)

• Duration of Enucleation and Morcellation Phases

  During the procedure.

• Number of Participants Requiring Blood Transfusion Post-Procedure

  From procedure date to 30 days.

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

  From procedure date to 30 days.

Study Arms (1)

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.

Device: Beacon Platform

Interventions

Beacon Platform DEVICE

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

A single-arm open label pilot study

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Any potential participants who were assigned male at birth (ie have a prostate) but do not identify as male may still participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Andromeda Surgical: lead

Study Sites (3)

Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 8320165, Chile

RECRUITING

Hospital Clínico de la Universidad de Chile

Santiago, Santiago Metropolitan, 8380453, Chile

RECRUITING

Tauranga Urology Research Limited

Tauranga, New Zealand

RECRUITING

Related Publications (4)

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

  PMID: 34453423 BACKGROUND

• 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.

  PMID: 32273963 BACKGROUND

• 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.

  PMID: 32876002 BACKGROUND

• 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.

  PMID: 31481144 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Peter Gilling, MD, FRACS

  Tauranga urology research

  PRINCIPAL INVESTIGATOR

• Rodrigo Ledezma, MD,

  University of Chile Clinical Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rami Abukhalil, MD. MPH

CONTACT

513-808-2097; rami@andromedasurgical.com

Michael Nketiah

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 31, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); CL (2)