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Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging
Sponsor: The Metis Foundation
Summary
The goal of this pilot clinical study is to evaluate the feasibility of collecting Spatial Frequency Domain Imaging (SFDI) data in patients with circulatory compromise due to thermal burns using the FDA-cleared Clarifi Imaging System and the next generation handheld m-Clarifi. Accurate assessment of burn depth and assessment at the point of care is an essential input for clinicians to plan proper treatment and management. SFDI has been shown to be a promising method to evaluate burn depth and extent within 24 hours in pre-clinical studies. The two feasibility goals of this study are as follows: 1) Do the values obtained with a commercial SFDI system provide utility in assessing burn depth in a clinical setting? And 2) Do Clarifi and m-Clarifi provide equivalent data when assessing subjects with burn injuries (biomarker imaging values, clinical workflow).
Official title: Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging (SFDI): An Observational Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
15
Start Date
2025-04
Completion Date
2025-12
Last Updated
2025-04-10
Healthy Volunteers
No
Conditions
Interventions
Spatial Frequency Domain Imaging
Spatial Frequency Domain Imaging captures at specific timepoints.
Locations (1)
The United States Army Institute of Surgical Resarch
Fort Sam Houston, Texas, United States