Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH

Launched by PROARC MEDICAL · Feb 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Omega System, which is designed to help relieve lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH), a condition where the prostate becomes enlarged and can cause difficulty urinating. The trial is looking at how safe and effective this device is when inserted into the prostate tissue during surgery called prostatectomy.

To be eligible for the trial, participants need to be men aged between 50 and 80 who are scheduled for prostate surgery and have specific prostate size requirements. Participants should also be willing to provide informed consent and cannot have certain health issues that could complicate the study. Those who join can expect close monitoring during the study to ensure their safety and to assess how well the Omega System works. It's important to note that this trial is currently recruiting participants, so if you or someone you know fits the criteria and is interested, there may be an opportunity to take part.

Gender

MALE

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.