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Safety and Efficacy Evaluation of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography
Sponsor: Trust Bio-sonics, Inc.
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.
Official title: A Prospective, Multicenter, Phase III Clinical Evaluation of the Safety and Efficacy of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-03-18
Completion Date
2027-02
Last Updated
2025-08-26
Healthy Volunteers
No
Conditions
Interventions
NH002 (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