Omega arc implant to relieve urinary symptoms from an enlarged prostate

Evaluation of the Safety, Tolerability and Efficacy the Omega System for the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

The study will try the Omega arc implant in men aged 50–80 undergoing prostatectomy to see if it safely reduces lower urinary tract symptoms from benign prostatic hyperplasia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 11 (estimated)
• Ages: 50 Years and up
• Sex: Male
• Sponsor: ProArc Medical (Industry-sponsored)
• Locations: 5 sites (Tbilisi and 4 other locations)
• Trial ID: NCT05757687 on ClinicalTrials.gov

What this trial studies

This is a prospective, two-stage, multi-center pilot study testing the Omega System, an arc-shaped implant delivered into prostate tissue, for men with LUTS due to BPH. The first stage places the device in patients who are already scheduled for prostatectomy to allow direct safety and tissue assessments in a setting where the prostates will later be removed. Outcomes will include measures of safety, tolerability, and preliminary efficacy on urinary symptoms and flow. The study is being conducted at multiple centers in Tbilisi, Georgia and is sponsored by ProArc Medical.

Who should consider this trial

Good fit: Men aged 50 to 80 with symptomatic BPH, prostate volume between 30 and 80 cc, and who are scheduled for a prostatectomy at a participating center are the intended participants for stage 1.

Not a fit: Patients who cannot stop anticoagulants/antiplatelets as required, those recently treated with alpha-blockers or 5‑α‑reductase inhibitors, or men outside the specified prostate size or not undergoing prostatectomy are unlikely to benefit from stage 1 participation.

Why it matters

Potential benefit: If successful, the Omega implant could provide a minimally invasive option to reduce urinary symptoms and improve urinary flow in men with BPH.

How similar studies have performed: Other minimally invasive intraprostatic implants and devices (for example, prostatic urethral lift systems) have shown symptomatic improvement, but the specific Omega arc implant appears to be a novel device with limited published clinical data to date.

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.

Where this trial is running

Tbilisi and 4 other locations

• N(N)LE New Vision University Hospital — Tbilisi, Georgia (Recruiting)
• Israeli-Georgian Medical Research Clinic Healthycore — Tbilisi, Georgia (Recruiting)
• JSC L.Managadze National Center of Urology — Tbilisi, Georgia (Recruiting)
• Tbilisi Heart Center — Tbilisi, Georgia (Recruiting)
• Todua Clinic — Tbilisi, Georgia (Terminated)

Study contacts

• Study coordinator: Fay Dan

Conditions Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia