Study of the Omega System Device for Treating Urinary Symptoms from Enlarged Prostate in Men Aged 50 and Older

What this Trial Is About

Researchers are evaluating the Omega System device for its safety, tolerability, and effectiveness in treating lower urinary tract symptoms LUTS caused by benign prostatic hyperplasia BPH in men aged 50 to 80 years. This pilot clinical study is conducted in two stages and involves multiple centers. Initially, the device is tested on patients scheduled for prostatectomy, even though the device is not indicated for this surgery, to assess its safety and functionality. The Omega System consists of a delivery device and an arc-shaped implant made of implantable nitinol coated with Parylene. During the procedure, the delivery system uses an electrode to make a circular incision through the urethral wall into the prostate tissue, where the implant is placed to expand the obstructed area and relieve fluid blockage in the prostatic urethra. Stage 1 focuses on patients undergoing prostatectomy, and Stage 2 involves patients with symptomatic BPH treated with the device, with follow-up evaluations at various intervals. Participants will undergo assessments including the incidence and severity of procedure- and device-related adverse events, post-operative catheter use, changes in urinary symptoms, urinary flow rates, prostate-specific antigen levels, sexual function, pain, residual urine volume, and inflammation. These evaluations occur on the procedure day and at 1, 3, 6, and 12 months after treatment. The study also monitors the usability of the device and tracks any need for repeat treatments or device removal over 12 months.

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