Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH
Trial Parameters
Brief Summary
The ProArc Medical Omega system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH. During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses a static diathermy incision mechanism to make a circumferential incision in the tissue surrounding the prostatic urethra into which the Omega shaped permanent implant is placed. The implant expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.
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)