Trials / Recruiting
RecruitingNCT06815627
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Trust Bio-sonics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-03-18
- Primary completion
- 2027-02-01
- Completion
- 2027-02-01
- First posted
- 2025-02-07
- Last updated
- 2025-08-26
Locations
6 sites across 1 country: Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06815627. Inclusion in this directory is not an endorsement.