NCT05757687 Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH
| NCT ID | NCT05757687 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ProArc Medical |
| Condition | Lower Urinary Tract Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 11 participants |
| Start Date | 2023-02-07 |
| Primary Completion | 2026-01-03 |
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 11 participants in total. It began in 2023-02-07 with a primary completion date of 2026-01-03.
⚠ 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
This is a prospective, two-stage, multi-center, pilot clinical study to evaluate the safety/tolerability/efficacy of the Omega System device. The Omega arc-shaped implant is inserted by the Omega delivery system into the prostate tissue of subjects to relieve lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). The study will first evaluate the Omega system on patients undergoing prostatectomy, which is not indicated for the device.
Eligibility Criteria
Stage 1 Inclusion Criteria: 1. Male ≥50 years of age and ≤ 80 years old. 2. Will undergo planned prostatectomy. 3. Participant understands and is willing to the informed consent form. 4. Prostate Volume between 30cc and 80cc. 5. Prostate length ≥ 3cm Exclusion Criteria: 1. Unable to comply with the clinical protocol. 2. Vulnerable population such as inmates or developmentally delayed individuals. 3. Any medical condition or treatment, which in the opinion of the investigator may interfere with the procedure, such as: * 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 is not prohibited). * Use of alpha-blockers within 2 weeks of pre-treatment (baseline) evaluation. * Use of 5-α-reductase inhibitors within 6 months of pre-treatment (baseline) evaluation. 4. American Society of Anesthesiologists score (ASA) \> 3. 5. Previous prostate surgery such as: TURP, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate. 6. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate. 7. Other urethral conditions that may prevent insertion of Delivery Device into prostatic urethra. 8. Previous rectal surgery, other than hemorrhoidectomy 9. Current gross hematuria. 10. Known allergy to nickel or titanium or stainless steel. Stage 2 Inclusion Criteria: 1. Male ≥50 years old. 2. Suspected 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. Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out. 2. Concomitant participation in another interventional study. 3. Unable to comply with the clinical protocol including all the follow-up requirements. 4. Vulnerable population such as inmates or developmentally delayed individuals. 5. Significant comorbidities which would affect study participation. 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 Anesthesiologists 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
Frank Mastandrea, Dr
STUDY DIRECTOR
Board Member and Medical Director
Frequently Asked Questions
Who can join the NCT05757687 clinical trial?
This trial is open to male participants only, aged 50 Years or older, studying Lower Urinary Tract Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05757687 currently recruiting?
Yes, NCT05757687 is actively recruiting participants. Contact the research team at fay@proarcmedical.com for enrollment information.
Where is the NCT05757687 trial being conducted?
This trial is being conducted at Tbilisi, Georgia, Tbilisi, Georgia, Tbilisi, Georgia, Tbilisi, Georgia and 1 additional location.
Who is sponsoring the NCT05757687 clinical trial?
NCT05757687 is sponsored by ProArc Medical. The principal investigator is Frank Mastandrea, Dr at Board Member and Medical Director. The trial plans to enroll 11 participants.