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NCT02282163 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography
A Phase 3 study, sponsored by Bracco Diagnostics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 13
- Enrollment target
NCT02282163: Clinical Trial Phase 3 study, sponsored by Bracco Diagnostics.
NCT02282163 is a Phase 3 study that was terminated before completion, run by Bracco Diagnostics. The registered enrollment target is 13 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02282163, a Phase 3 study, was terminated before completion, sponsored by Bracco Diagnostics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 13 participants
- Enrollment target
Study Summary
Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV EBD on non-contrast 2D echocardiography. Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.
Primary Outcome
The total LV EBD score for a subject was the total of the EBD scores (Inadequate - 0, sufficient - 1, Good - 2) from the 17 segments (from the apical 4-chamber, apical 2-chamber and apical long (3-chamber) views, according to the guidelines of the American Society of Echocardiography). The total LV EBD scores could range from 0 to 34 and are presented below for each of the three readers for both unenhanced ultrasound (UEUS) and contrast-enhanced ultrasound (CEUS). Change from baseline is the di
Interventions
- DRUG sulphur hexafluoride lipid-type A microspheres
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2015-10 |
| Est. Completion | 2018-08 |
| Phase | Phase 3 |
Why NCT02282163 stopped before completion
NCT02282163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which sulphur hexafluoride lipid-type A microspheres is the first listed.
NCT02282163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02282163 about?
NCT02282163 is a clinical study titled "Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography". Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV EBD on non-contrast 2D echocardiography. Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.
What is the current status of trial NCT02282163?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 13 participants. The study started on 2015-10. Estimated completion is 2018-08.
What interventions are being tested in trial NCT02282163?
The interventions under investigation include: sulphur hexafluoride lipid-type A microspheres (DRUG).
Who is sponsoring clinical trial NCT02282163?
This trial is sponsored by Bracco Diagnostics, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02282163's enrollment target sits among peer trials
13 1984th of 2000 higher than 17 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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