Benign Prostatic HyperplasiaNCT04627701
Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH
A study testing Omega in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by ProArc Medical at 4 sites in 2 countries.
Trial summary
The ProArc Medical Omega system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH. During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Omega
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Jul 2023to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male ≥50 years of age
- Diagnosed with symptomatic benign prostatic hyperplasia (BPH).
- International Prostate Symptom Score (IPSS) >13.
- Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml).
- Participant understands and is willing to the informed consent form.
- Prostate Volume between 30cc and 80cc.
- Prostate length ≥3cm and ≤5cm
Who cannot join
- Concomitant participation in another interventional study.
- Unable to comply with the clinical protocol including all the follow-up requirements.
- Vulnerable population such as inmates or developmentally delayed individuals.
- Significant comorbidities which would affect study participation.
- Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out.
- Any medical condition or treatment, which in the opinion of the investigator may interfere with the procedure, such as:
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- 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]
- Previous prostate surgery such as: TURP, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate.
- Compromised renal function due to obstructive uropathy.
- Active Urinary Tract Infection (UTI).
- Obstructive or protruding median lobe
- American Society of Anaesthesiologists score (ASA) > 3.
- Known neurogenic bladder or neurological disorders that might affect bladder or function.
- Recent myocardial infarction (less than three months).
- Concomitant bladder stones.
- Current gross hematuria.
- Active or history of epididymitis within the past 3 months.
- Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate.
- Confirmed or suspected malignancy of bladder.
- History or presence of strictures in the anterior urethra or bladder neck contracture or detrusor muscle spasms.
- Other Urethral conditions that may prevent insertion of Delivery Device into prostatic urethra.
- Bacterial prostatitis within the last 12 months.
- Previous rectal surgery, other than hemorrhoidectomy.
- Current uncontrolled diabetes (i.e., hemoglobin A1c ≥ 9%).
- Known allergy to nickel or titanium or stainless steel.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Israel3 sites
Soroka Medical Center
Beersheba
Carmel Medical Center
Haifa
Rambam Health Care Campus
Haifa
About this study
Official title: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of Benign Prostatic Hyperplasia
The ProArc Medical Omega system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH. During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses a static diathermy incision mechanism to make a circumferential incision in the tissue surrounding the prostatic urethra into which the Omega shaped permanent implant is placed. The implant expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.
- Being tested
- Omega
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegaDevice
Omega Implantation
| Study group | Role | What they receive |
|---|---|---|
| Omega Device | Experimental | Not described Receives: Device: Omega |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in urinary related symptoms as evidenced by IPSS score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start23 Jul 2023
- Primary completion30 Apr 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProArc Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627701
- Sponsor's protocol ID
- PA-CP-20
- Status last verified
- Sep 2026
- First submitted
- 8 Nov 2020
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the Omega System for the Treatment of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT04627701
- Acronym / sponsor ID
- PA-CP-20
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- ProArc MedicalIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ProArc Medical Omega system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH. During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses a static diathermy incision mechanism to make a circumferential incision in the tissue surrounding the prostatic urethra into which the Omega shaped permanent implant is placed. The implant expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega Device | Experimental | Device: Omega |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male ≥50 years of age
- Diagnosed with symptomatic benign prostatic hyperplasia (BPH).
- International Prostate Symptom Score (IPSS) >13.
- Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml).
- Participant understands and is willing to the informed consent form.
Key exclusion criteria (29 listed)
- Concomitant participation in another interventional study.
- Unable to comply with the clinical protocol including all the follow-up requirements.
- Vulnerable population such as inmates or developmentally delayed individuals.
- Significant comorbidities which would affect study participation.
- Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmegaOmega Implantation | Device | Omega Device |
Primary outcome
Improvement in urinary related symptoms as evidenced by IPSS score
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by ProArc Medical at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in urinary related symptoms as evidenced by IPSS score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.