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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04627701




Registration number
NCT04627701
Ethics application status
Date submitted
8/11/2020
Date registered
13/11/2020
Date last updated
7/08/2025

Titles & IDs
Public title
Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH
Scientific title
Evaluation of the Safety and Efficacy of the Omega System for the Treatment of Benign Prostatic Hyperplasia
Secondary ID [1] 0 0
PA-CP-20
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Lower Urinary Tract Symptoms 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 - Omega

Experimental: Omega Device -


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

Outcomes
Primary outcome [1] 0 0
Improvement in urinary related symptoms as evidenced by IPSS score
Timepoint [1] 0 0
3 months

Eligibility
Key inclusion criteria
1. Male =50 years of age
2. Diagnosed with symptomatic benign prostatic hyperplasia (BPH).
3. International Prostate Symptom Score (IPSS) >13.
4. Peak flow rate = 12 ml/sec (with voided volume = 125ml).
5. Participant understands and is willing to the informed consent form.
6. Prostate Volume between 30cc and 80cc.
7. Prostate length =3cm and =5cm
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Concomitant participation in another interventional study.
2. Unable to comply with the clinical protocol including all the follow-up requirements.
3. Vulnerable population such as inmates or developmentally delayed individuals.
4. Significant comorbidities which would affect study participation.
5. Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out.
6. Any medical condition or treatment, which in the opinion of the investigator may interfere with the procedure, such as:

* Use of concomitant medications (e.g., anticholinergics, antispasmodics, or antidepressants) affecting bladder function.
* Patient with coagulopathy due to medications or congenital condition - inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure; low dose aspirin therapy not prohibited.
* Alpha-blockers within 2 weeks of pre-treatment (baseline) evaluation.
* Taking 5-alpha reductase inhibitors (5-ARI) within 6 months (3 months for type II 5-ARI) of pre-treatment (baseline) evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued throughout the study).
* Patient is taking steroids. [Note: Patients approved for the trial who are using the above medications will continue using them after the trial, except for Alpha blockers]
7. Previous prostate surgery such as: TURP, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate.
8. Compromised renal function due to obstructive uropathy.
9. Active Urinary Tract Infection (UTI).
10. Obstructive or protruding median lobe
11. American Society of Anaesthesiologists score (ASA) > 3.
12. Known neurogenic bladder or neurological disorders that might affect bladder or function.
13. Recent myocardial infarction (less than three months).
14. Concomitant bladder stones.
15. Current gross hematuria.
16. Active or history of epididymitis within the past 3 months.
17. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate.
18. Confirmed or suspected malignancy of bladder.
19. History or presence of strictures in the anterior urethra or bladder neck contracture or detrusor muscle spasms.
20. Other Urethral conditions that may prevent insertion of Delivery Device into prostatic urethra.
21. Bacterial prostatitis within the last 12 months.
22. Previous rectal surgery, other than hemorrhoidectomy.
23. Current uncontrolled diabetes (i.e., hemoglobin A1c = 9%).
24. Known allergy to nickel or titanium or stainless steel.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Actual
23/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Israel
State/province [1] 0 0
Beersheba
Country [2] 0 0
Israel
State/province [2] 0 0
Haifa
Country [3] 0 0
New Zealand
State/province [3] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ProArc Medical
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Fay Dan
Address 0 0
Country 0 0
Phone 0 0
+972 54-478-1599
Fax 0 0
Email 0 0
[email protected]
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/NCT04627701