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

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Evaluation of the Safety and Efficacy of the Omega System for the Treatment of Benign Prostatic Hyperplasia

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04627701
Study type Interventional
Source ProArc Medical
Contact Fay Dan
Phone +972 54-478-1599
Email Fay@proarcmedical.com
Status Recruiting
Phase N/A
Start date July 23, 2023
Completion date December 2024
View Details
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