Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH

Launched by PROARC MEDICAL · Nov 8, 2020

Keywords

ClinConnect Summary

The Omega Study is a clinical trial designed to evaluate a new treatment for men with benign prostatic hyperplasia (BPH), a condition that can cause uncomfortable urinary symptoms. The treatment involves a device called the Omega system, which reshapes the prostate to help ease the flow of urine. During the procedure, a small implant is placed in the prostate to expand the area that may be blocking the urethra, making it easier to urinate. This trial is currently looking for male participants who are at least 50 years old and have moderate to severe symptoms related to BPH.

To be eligible for the trial, participants must have a specific score indicating their urinary symptoms and meet certain health criteria, such as having a prostate size within a certain range. If you decide to participate, you can expect to undergo the procedure and have regular follow-up assessments to monitor your progress. It's important to note that some individuals, such as those with certain medical conditions or previous prostate surgeries, may not be able to join the study. If you think you might qualify and are interested in learning more, please reach out for additional information.

Gender

MALE

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.