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

NCT06815627 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-08-26

No results posted yet for this study

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.

Conditions

  • Cardiac Diseases

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.

Sponsors & Collaborators

  • CMIC ASIA-PACIFIC, PTE. LTD., TAIWAN BRANCH

    collaborator UNKNOWN

  • Trust Bio-sonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Wen-Chung Yu · Taipei Veterans General Hospital, Taiwan

  • Chung-Lieh Hung · Mackay Memorial Hospital

  • Chih-Hui Chin · Cathay General Hospital

  • Hsin-Yueh Liang · China Medical University Hospital

  • Ning-I Yang · Chang Gung Memorial Hospital

  • Chien-Boon Jong · National Taiwan University Hospital Hsin-Chu Branch

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-18
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06815627 on ClinicalTrials.gov