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

Not Applicable

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT06668142
• Lead Sponsor: Andromeda Surgical

Brief Summary

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 Timeline

• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-10-31
• Study Start: 2024-12-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants Successfully Completing Robot-Assisted HoLEP (Enucleation and Morcellation) Without Conversion	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 )	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Capsular Perforation Leading to Procedure Interruption or Conversion	From procedure date to 30 days.	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
Number of Participants with Bladder Perforation Leading to Procedure Interruption or Conversion	From procedure date to 30 days.	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.
Operative Time for Procedure Completion	During the procedure.	This outcome measures the total time required to complete the HoLEP procedure.
Number of Participants with Ureteric Orifice Damage Requiring Intervention	From procedure date to 30 days.	This outcome assesses the incidence of ureteric orifice damage leading to stricture, stenting, or any other sequelae or subsequent intervention.
Length of Hospital Stay Post-Procedure	From procedure date to 30 days	This outcome measures the total length of hospital stay required following the HoLEP procedure.
Length of Catheterization Post-Procedure	From procedure date to 30 days	This outcome measures the total duration of catheterization following the procedure.
Number of Participants with Repeat Hospitalization for Genitourinary Conditions	From procedure date to 30 days post-procedure.	This outcome measures the incidence of repeat hospitalizations due to genitourinary conditions within 30 days post-procedure.

Trial Locations

Locations (3)

Universidad Catolica de Chile; 🇨🇱 Santiago, Región Metropolitana, Chile

Hospital Clínico de la Universidad de Chile; 🇨🇱 Santiago, Región Metropolitana, Chile

Tauranga Urology Research Limited; 🇳🇿 Tauranga, New Zealand