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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06668142




Registration number
NCT06668142
Ethics application status
Date submitted
23/10/2024
Date registered
31/10/2024

Titles & IDs
Public title
A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
Scientific title
A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
Secondary ID [1] 0 0
ASTRA112024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Beacon Platform

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.


Treatment: Devices: 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Successfully Completing Robot-Assisted HoLEP (Enucleation and Morcellation) Without Conversion
Timepoint [1] 0 0
During the procedure.
Primary outcome [2] 0 0
Number of subjects with adverse events ( Clavien-Dindo Grade 3a or higher )
Timepoint [2] 0 0
From procedure date to 30 days
Secondary outcome [1] 0 0
Number of Participants with Capsular Perforation Leading to Procedure Interruption or Conversion
Timepoint [1] 0 0
From procedure date to 30 days.
Secondary outcome [2] 0 0
Number of Participants with Bladder Perforation Leading to Procedure Interruption or Conversion
Timepoint [2] 0 0
From procedure date to 30 days.
Secondary outcome [3] 0 0
Number of Participants with Ureteric Orifice Damage Requiring Intervention
Timepoint [3] 0 0
From procedure date to 30 days.
Secondary outcome [4] 0 0
Length of Hospital Stay Post-Procedure
Timepoint [4] 0 0
From procedure date to 30 days
Secondary outcome [5] 0 0
Length of Catheterization Post-Procedure
Timepoint [5] 0 0
From procedure date to 30 days
Secondary outcome [6] 0 0
Operative Time for Procedure Completion
Timepoint [6] 0 0
During the procedure.
Secondary outcome [7] 0 0
Number of Participants with Repeat Hospitalization for Genitourinary Conditions
Timepoint [7] 0 0
From procedure date to 30 days post-procedure.

Eligibility
Key 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
Minimum age
45 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
12/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2025
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Chile
State/province [1] 0 0
Región Metropolitana
Country [2] 0 0
New Zealand
State/province [2] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Andromeda Surgical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Gilling, MD, FRACS
Address 0 0
Tauranga urology research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rami Abukhalil, MD. MPH
Address 0 0
Country 0 0
Phone 0 0
513-808-2097
Fax 0 0
Email 0 0
rami@andromedasurgical.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06668142