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

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Evaluation of the Safety, Tolerability and Efficacy the Omega System for the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05757687
Study type Interventional
Source ProArc Medical
Contact Fay Dan
Phone 972-544-781-599
Email fay@proarcmedical.com
Status Recruiting
Phase N/A
Start date February 7, 2023
Completion date December 1, 2024
View Details
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