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NOT YET RECRUITING
NCT06921421

Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

Sponsor: The Metis Foundation

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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