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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 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 267 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05025449
The ClinicalTrials.gov registry entry for NCT05025449 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Focused Assessment with Sonography for Trauma (FAST) is the first listed.
NCT05025449 reports 0 study locations.
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.
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