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| ID | Type | Description | Link |
|---|---|---|---|
| MTEC-22-08-BDA-007 | Other Grant/Funding Number | Medical Technology Enterprise Consortium |
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| Name | Class |
|---|---|
| United States Army Institute of Surgical Research | FED |
| Modulated Imaging Inc. | INDUSTRY |
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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spatial Frequency Domain Imaging | Diagnostic Test | Spatial Frequency Domain Imaging captures at specific timepoints. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean SFDI Scattering Parameter (mm-¹) at Burn Injury Sites Using Clarifi and m-Clarifi Imaging Systems | This outcome will report the mean value of the scattering coefficient (μs'), a quantitative SFDI-derived biomarker that correlates with burn depth, measured at specified time points (Day 0, 3, 7, 14, and 21) using the Clarifi and m-Clarifi imaging systems. Higher scattering values are associated with deeper tissue damage. | From enrollment to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between SFDI Scattering Parameter and Clinician-Determined Burn Depth | This outcome evaluates the statistical correlation between SFDI scattering values and the burn depth classifications made by clinicians based on visual assessment and standard clinical criteria (e.g., superficial partial, deep partial, full thickness). | From enrollment to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement Between Clarifi and m-Clarifi Devices in Measuring SFDI Scattering Parameter | This outcome assesses the agreement between SFDI scattering measurements obtained from the Clarifi (FDA-cleared) and m-Clarifi (handheld prototype) devices at the same anatomical burn sites. Agreement will be quantified using Bland-Altman analysis and intraclass correlation coefficients (ICCs). | From enrollment to 21 days |
Inclusion Criteria:
Exclusion Criteria:
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Patients receiving care at the US Army Institute of Surgical Research (USAISR) Burn Center with thermal burn injuries will be considered for enrollment into this study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Diaz, BSN | Contact | 210-201-2206 | diaz@metisfoundationusa.org |
| Name | Affiliation | Role |
|---|---|---|
| Rodney Chan, MD | The Metis Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The United States Army Institute of Surgical Resarch | Fort Sam Houston | Texas | 78234 | United States |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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