NCT04627701 Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH
| NCT ID | NCT04627701 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ProArc Medical |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2023-07-23 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 26 participants in total. It began in 2023-07-23 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04627701 clinical trial?
This trial is open to male participants only, aged 50 Years or older, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04627701 currently recruiting?
Yes, NCT04627701 is actively recruiting participants. Contact the research team at Fay@proarcmedical.com for enrollment information.
Where is the NCT04627701 trial being conducted?
This trial is being conducted at Beersheba, Israel, Haifa, Israel, Haifa, Israel, Tauranga, New Zealand.
Who is sponsoring the NCT04627701 clinical trial?
NCT04627701 is sponsored by ProArc Medical. The trial plans to enroll 26 participants.