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NCT05025449 · ClinicalTrials.gov registry record · Phase 4
BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 267
- Enrollment target
NCT05025449: Completed Phase 4 study, sponsored by Emory University.
NCT05025449 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 267 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05025449, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 267 participants
- Enrollment target
Study Summary
The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of advanced trauma life support (ATLS) protocol, but its low sensitivity for identifying solid organ injury in the absence of hemoperitoneum is a significant limitation. Contrast-enhanced ultrasound (CEUS) has the potential to significantly enhance the evaluation of the trauma patient with acute intra-abdominal injury through the use of intravascular microbubbles that allow direct visualization of lacerations to solid organs. European studies have demonstrated that ultrasound contrast markedly improves the sensitivity of ultrasound in detecting solid organ injury, when the exam is performed in the radiology suite. The researchers hypothesize that the bubble-enhanced FAST or BEFAST exam will be more sensitive than traditional FAST for identification of solid organ injury in hemodynamically stable blunt abdominal trauma patients when performed by emergency providers.
Primary Outcome
The performance of the study exams will be assessed as the number of correctly identified solid organ injuries (true positives) detected by FAST exam and BEFAST exam. The presence of injury will be determined by the gold standard of a CT exam, conducted within 24 hours as part of the standard of care.
Interventions
- DIAGNOSTIC_TEST Focused Assessment with Sonography for Trauma (FAST)
- DRUG Bubble-Enhanced FAST (BEFAST)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2021-09-30 |
| Est. Completion | 2023-09-14 |
| Phase | Phase 4 |
What the finished NCT05025449 record still lists
NCT05025449 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Focused Assessment with Sonography for Trauma (FAST) is the first listed.
NCT05025449 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05025449 about?
NCT05025449 is a clinical study titled "BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury". The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of advanced trauma life support (ATLS) protocol, but its low sensitivity for identifying solid organ injury in the absence of hemoperitoneum is a significant limitation. Contrast-enhanced ultrasound (CE...
What is the current status of trial NCT05025449?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 267 participants. The study started on 2021-09-30. Estimated completion is 2023-09-14.
What interventions are being tested in trial NCT05025449?
The interventions under investigation include: Focused Assessment with Sonography for Trauma (FAST) (DIAGNOSTIC_TEST), Bubble-Enhanced FAST (BEFAST) (DRUG).
Who is sponsoring clinical trial NCT05025449?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05025449's enrollment target sits among peer trials
267 320th of 2000 higher than 1,681 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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