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Clinical Trial

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

NCT: NCT05757687 · ACTIVE_NOT_RECRUITING

NCT IDNCT05757687
StatusACTIVE_NOT_RECRUITING
Start Date2023-02-07
Completion2027-02-01
SponsorProArc Medical (INDUSTRY)
First posted
Last updated

Brief 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.

Frequently Asked Questions

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

Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH is a clinical trial registered under NCT05757687. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT05757687?

The current status of NCT05757687 (Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH) is: ACTIVE_NOT_RECRUITING.

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

Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH started on 2023-02-07.

Related Devices

PMA P010055System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapyProstalund AB PMA P030006System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapyMedifocus, Inc.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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