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NCT03740997 · ClinicalTrials.gov registry record · Phase 4
Study to Determine Safety and Dosage of OPTISON in Pediatric Participants
A Phase 4 study of Transthoracic Echocardiography and Suspected or Known Structural or Functional Cardiac Abnormality, sponsored by GE Healthcare.
- Completed
- Registry status
- Phase 4
- Development phase
- 39
- Enrollment target
- 8
- Study locations
NCT03740997: Completed Phase 4 study of Transthoracic Echocardiography and Suspected or Known Structural or Functional Cardiac Abnormality, sponsored by GE Healthcare.
NCT03740997 is a Phase 4 study of Transthoracic Echocardiography and Suspected or Known Structural or Functional Cardiac Abnormality that has completed, run by GE Healthcare. The registered enrollment target is 39 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03740997, a Phase 4 study of Transthoracic Echocardiography and Suspected or Known Structural or Functional Cardiac Abnormality, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 39 participants
- Enrollment target
- 8
- Study locations
Study 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
Primary Outcome
Visualization of each of the 12 segments of the LV wall in standard A4C and A2C views were measured by the qualitative EBD visualization scale: score 0 =no visualization of the LV endocardial border; 1 =poor visualization; 2 =fair visualization; 3 =good/optimal visualization. The total LV EBD score was calculated as the sum of the individual scores assigned to each of the 12 LV wall segment and the total score ranged from 0 (no visualization of the LV endocardial border) to 36 (good/optimal visu
Conditions Studied
Interventions
- DRUG Optison
Study Locations (8)
Arizona
- Phoenix Children's Hospital - Phoenix
California
- Children's Hospital Los Angeles - Los Angeles
Georgia
- MCG Health, Inc. - Augusta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Maryland
- Johns Hopkins University School of Medicine - Baltimore
New York
- Cohen Children's Medical Center of New York - Lake Success
Ohio
- Cleveland Clinic Foundation - Cleveland
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2023-03-30 |
| Phase | Phase 4 |
What the finished NCT03740997 record still lists
NCT03740997 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Transthoracic Echocardiography appearing as the primary indexed condition, and to 1 intervention - of which Optison is the first listed.
NCT03740997 lists 8 locations in 8 states (Arizona, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT03740997 about?
NCT03740997 is a clinical study titled "Study to Determine Safety and Dosage of OPTISON in Pediatric Participants". 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
What is the current status of trial NCT03740997?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 39 participants. The study started on 2020-12-01. Estimated completion is 2023-03-30.
What conditions does trial NCT03740997 study?
This clinical trial studies the following conditions: Transthoracic Echocardiography, Suspected or Known Structural or Functional Cardiac Abnormality.
What interventions are being tested in trial NCT03740997?
The interventions under investigation include: Optison (DRUG).
Who is sponsoring clinical trial NCT03740997?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03740997 being conducted?
This trial has 8 study locations across Arizona, California, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03740997's enrollment target sits among peer trials
39 1468th of 2000 higher than 526 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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