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