NCT03740997

Study to Determine Safety and Dosage of OPTISON in Pediatric Participants

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 9 Years – 17 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Optison	Optison is administered intravenously

Timeline

• Start date: 2020-12-01
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2018-11-14
• Last updated: 2024-05-17
• Results posted: 2024-05-17

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study