Prostate implant aims to relieve urinary symptoms without daily pills

NCT ID NCT04627701

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 22, 2026 · Last updated Sep 22, 2026

Summary

Researchers are testing a device called the Omega System in men aged 50 and older who have urinary symptoms from an enlarged prostate, also known as benign prostatic hyperplasia. The procedure uses heat to make a cut in the prostate tissue around the urethra, then places a permanent Omega-shaped implant that holds the passage open. The trial measures changes in urinary symptoms using a standard questionnaire. The study is small, with 26 participants, and is designed to assess safety and potential benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Omega implant, a permanent device placed in the prostate to widen the urethra
What this could lead to
If it works, this could offer men with an enlarged prostate a one-time procedure that eases urinary symptoms without daily medication.
What could go wrong
This is a small, early study of 26 men, so safety and benefit are not yet established. Implant procedures carry risks of bleeding, infection, or urinary problems, and the device may not relieve symptoms better than existing options.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Lower Urinary Tract Symptoms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Carmel Medical Center

    Haifa, Israel

  • Rambam Health Care Campus

    Haifa, Israel

  • Soroka Medical Center

    Beersheba, Israel

  • Tauranga Urology Research Limited

    Tauranga, New Zealand

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