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Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Trial status changed: Not Yet Recruiting → Active, Not Recruiting Show 5 more changesShow less
    • Primary completion date changed from estimate of Dec 2025 to Apr 10, 2026
    • Study completion pushed from Dec 2025 to Oct 2026
    • Start date changed from estimate of Apr 2025 to Jun 3, 2025
    • Site contact updated
    • Eligibility criteria expanded, about 4 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06921421
Lead Sponsor The Metis Foundation
Collaborators: United States Army Institute of Surgical Research, Modulated Imaging Inc.
Conditions
(from sponsor)		 Burn, Burn Injury
Related terms Burns
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov