Condition: Lower Urinary Tract Symptoms · Benign Prostatic Hyperplasia · Sponsor: ProArc Medical
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.
This description comes directly from the study's public registry record.
Fay Dan · 972-544-781-599 · fay@proarcmedical.com
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT05757687