RecruitingPhase 3NCT06815627

Safety and Efficacy Evaluation of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography

A Prospective, Multicenter, Phase III Clinical Evaluation of the Safety and Efficacy of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography


Sponsor

Trust Bio-sonics, Inc.

Enrollment

150 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 3, prospective, open-label, multicenter study to assess the efficacy of NH002-enhanced echocardiography in subjects with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the left ventricular endocardial border delineation compared with unenhanced echocardiography. The study also aims to investigate the safety and tolerability of NH002.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called NH002 (Perflutren Lipid Microspheres) Injectable Suspension for people with cardiac diseases. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNH002 (Perflutren Lipid Microspheres) Injectable Suspension

NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.


Locations(6)

Keelung Chang Gung Memorial Hospital & Lovers Lake Branch

Keelung, Taiwan

China Medical University Hospital

Taichung, Taiwan

MacKay Memorial Hospital

Taipei, Taiwan

Cathay General Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

National Taiwan University Hospital Hsin-Chu Branch

Zhubei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06815627


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