Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

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).

NCT Number	NCT06921421
Lead Sponsor	The Metis Foundation Collaborators: United States Army Institute of Surgical Research, Modulated Imaging Inc.
Conditions	Burn, Burn Injury
Enrollment	15 participants
Start Date	2025-04
Primary Completion	2025-12 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2025-04-10