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Study identifier: NCT04627701 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH

Condition: Benign Prostatic Hyperplasia · Lower Urinary Tract Symptoms  ·  Sponsor: ProArc Medical

PhaseNA
Planned participants26
Who can joinMale, 50 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Fay Dan  ·  +972 54-478-1599  ·  Fay@proarcmedical.com

Gilad Hizkiyahu  ·  +972 52-241-5544  ·  gilad@proarcmedical.com

Always discuss trial participation with your own doctor first.

Locations (4)

Soroka Medical CenterBeersheba, IsraelTerminated
Carmel Medical CenterHaifa, IsraelTerminated
Rambam Health Care CampusHaifa, IsraelTerminated
Tauranga Urology Research LimitedTauranga, New ZealandRecruiting

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Source record: clinicaltrials.gov/study/NCT04627701