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Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

NCT06921421 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2025-04-10

No results posted yet for this study

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).

Conditions

  • Burn
  • Burn Injury

Interventions

DIAGNOSTIC_TEST

Spatial Frequency Domain Imaging

Spatial Frequency Domain Imaging captures at specific timepoints.

Sponsors & Collaborators

  • The United States Institute of Surgical Research

    collaborator UNKNOWN

  • Modulated Imaging Inc.

    collaborator INDUSTRY

  • The Metis Foundation

    lead OTHER

Principal Investigators

  • Rodney Chan, MD · The Metis Foundation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06921421 on ClinicalTrials.gov