Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH
Recruiting now · Not applicable
Conditions studied: Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
In brief
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.
Key facts
- Study ID
- NCT05757687
- Run by
- ProArc Medical
- People needed
- 11
- Starts
- 2023-02-07
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2025-08-07
Who can join
Age: 50 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Male ≥50 years of age and ≤ 80 years old.
- Will undergo planned prostatectomy.
- Participant understands and is willing to the informed consent form.
- Prostate Volume between 30cc and 80cc.
- Prostate length ≥ 3cm
You may not qualify if…
- Unable to comply with the clinical protocol.
- Vulnerable population such as inmates or developmentally delayed individuals.
- 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.
- American Society of Anesthesiologists score (ASA) > 3.
- Previous prostate surgery such as: TURP, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate.
- Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate.
- Other urethral conditions that may prevent insertion of Delivery Device into prostatic urethra.
- Previous rectal surgery, other than hemorrhoidectomy
- Current gross hematuria.
- Known allergy to nickel or titanium or stainless steel.
- Stage 2
- Inclusion Criteria:
- Male ≥50 years old.
- Suspected symptomatic benign prostatic hyperplasia (BPH).
- International Prostate Symptom Score (IPSS) >13.
- Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml).
- Participant understands and is willing to the informed consent form.
- Prostate Volume between 30cc and 80cc.
- Prostate length ≥ 3cm and ≤ 5cm
- Exclusion Criteria:
- Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out.
- Concomitant participation in another interventional study.
Where it is running
- N(N)LE New Vision University Hospital — Tbilisi, Georgia (enrolling)
- Israeli-Georgian Medical Research Clinic Healthycore — Tbilisi, Georgia (enrolling)
- JSC L.Managadze National Center of Urology — Tbilisi, Georgia (enrolling)
- Tbilisi Heart Center — Tbilisi, Georgia (enrolling)
- Todua Clinic — Tbilisi, Georgia
Full record on ClinicalTrials.gov
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