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RECRUITING
NCT06815627
PHASE3

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

Sponsor: Trust Bio-sonics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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