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Completed Phase 4 Interventional Results available

Study to Determine Safety and Dosage of OPTISON in Pediatric Participants

ClinicalTrials.gov ID: NCT03740997

Public ClinicalTrials.gov record NCT03740997. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 10:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Study to determine the safety and appropriate dosage of OPTISON in pediatric participants since OPTISON has been tested in adult participants only during the clinical development

Study identification

NCT ID
NCT03740997
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
GE Healthcare
Industry
Enrollment
39 participants

Conditions and interventions

Eligibility (public fields only)

Age range
9 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 1, 2020 (Actual)
Primary completion
Mar 30, 2023 (Actual)
Completion
Mar 30, 2023 (Actual)
Last update posted
May 17, 2024

2020 – 2023

United States locations

U.S. sites
8
U.S. states
8
U.S. cities
8
Facility City State ZIP Site status
Phoenix Children's Hospital Phoenix Arizona 85016 —
Children's Hospital Los Angeles Los Angeles California 90027 —
MCG Health, Inc. Augusta Georgia 30912 —
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 —
Johns Hopkins University School of Medicine Baltimore Maryland 21287 —
Cohen Children's Medical Center of New York Lake Success New York 11042 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Baylor College of Medicine Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03740997, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 17, 2024 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03740997 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →