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NCT05167461 · ClinicalTrials.gov registry record
AutoMated BUrn Diagnostic System for Healthcare (AMBUSH)
A clinical trial, sponsored by Indiana University.
- Completed
- Registry status
- 30
- Enrollment target
NCT05167461: Completed study, sponsored by Indiana University.
NCT05167461 is a clinical trial that has completed, run by Indiana University. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05167461 has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
The primary objective of this study is to develop a high accuracy and automated system that can provide early assessment of burn injuries with at least 90% accuracy in absence of burn experts, using AI and FDA cleared harmonic ultrasound TDI data based on the analysis of mechanical and hemodynamic properties of the subcutaneous burned tissue. Data collected in this study will lead to the development of better diagnostic tools that could inform clinical burn practices by enabling doctors to determine burn depth and the need for surgery with greater speed and accuracy, resulting in better clinical outcomes.
Primary Outcome
Compare human assessment of burn depth to the technology output (Artificial Intelligence and TDI) as determined by need for surgery (time points include day 0 +/- 3 days). Biopsy collected from patients that go to OR (one-time collection) to verify the burn depth via histological analysis.
Interventions
- OTHER Collection of imaging by ultrasonography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-05-24 |
| Est. Completion | 2023-05-25 |
What the finished NCT05167461 record still lists
NCT05167461 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Collection of imaging by ultrasonography is the first listed.
NCT05167461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05167461 about?
NCT05167461 is a clinical study titled "AutoMated BUrn Diagnostic System for Healthcare (AMBUSH)". The primary objective of this study is to develop a high accuracy and automated system that can provide early assessment of burn injuries with at least 90% accuracy in absence of burn experts, using AI and FDA cleared harmonic ultrasound TDI data based on the analysis of mechanical and hemodynamic p...
What is the current status of trial NCT05167461?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2022-05-24. Estimated completion is 2023-05-25.
What interventions are being tested in trial NCT05167461?
The interventions under investigation include: Collection of imaging by ultrasonography (OTHER).
Who is sponsoring clinical trial NCT05167461?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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