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Study to Determine Safety and Dosage of OPTISON in Pediatric Participants

NCT03740997 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-05-17

Study results available
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Summary

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

Conditions

  • Transthoracic Echocardiography
  • Suspected or Known Structural or Functional Cardiac Abnormality

Interventions

DRUG

Optison

Optison is administered intravenously

Sponsors & Collaborators

  • Laboratory Corporation of America

    collaborator INDUSTRY

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • David Thompson, MD, PhD · GE Healthcare

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-03-30
Completion
2023-03-30
FDA Drug
Yes

Countries

  • United States

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 NCT03740997 on ClinicalTrials.gov