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- (OPTISON) A Phase 4, Open-Label, Non-randomized, Multicenter Study to Evaluate Safety and Efficacy of Intravenous Administration of OPTISON™ for Contrast-Enhanced Echocardiography in Pediatric Patients
Clinical Trial
(OPTISON) A Phase 4, Open-Label, Non-randomized, Multicenter Study to Evaluate Safety and Efficacy of Intravenous Administration of OPTISON™ for Contrast-Enhanced Echocardiography in Pediatric Patients
This study is to see how safe OPTISON (TM) is and how well it works with children. It has been used with adults to improve medical images of the heart using an echocardiogram (ECHO). This study will use OPTISON (TM) with children who are having an ECHO of their heart.
Eligibility Criteria
- Inclusion: at least 9 years old through 18 years old weighs at least 20 kilograms clinically indicated to undergo a transthoracic echocardiogram has a previous suboptimal non-contrast echocardiogram is able to comply with study procedures Exclusion: positive pregnancy test presence of pulmonary hypertension, unstable cardiopulmonary condition, severe liver disease, or life-threatening disease with short life expectancy (less than 1 month).
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