Status:
COMPLETED
Burn Validation Study
Lead Sponsor:
SpectralMD
Conditions:
Burns
Wound Heal
Eligibility:
All Genders
Brief Summary
The purpose of this study is to validate the algorithm for burn healing assessment by the Spectral MD DeepView device which would provide burn healing potential assessment.
Eligibility Criteria
Inclusion
- Willing and able to give informed consent or have a Legally Authorized Representative (LAR) able to do so; Life expectancy \> 6 months; Thermal burn mechanism (flame, scald, or contact); The Study Burn(s) occurred less than 72 hours prior to the time of first imaging; and Minimum burn wound size for adult or pediatric patients is 0.5% TBSA per region For adult Subjects: Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn.
- For pediatric Subjects: Have 1 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn
Exclusion
- Burn pattern distribution isolated to head, face, neck, hands, feet, genitalia, and/or joints; Subject has burns involving \> 50% total body surface area (TBSA); Sepsis at the time of enrollment; Immunosuppression/radiation/chemotherapy \< 3 months prior to enrollment; Concurrent use of investigational products with a known effect on the burn sites; and/or Any condition that in the opinion of the Investigator may prevent compliance with the study requirements or compromise subject safety.
Key Trial Info
Start Date :
December 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT06131203
Start Date
December 19 2023
End Date
April 1 2025
Last Update
April 25 2025
Active Locations (21)
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1
Valleywise Health
Phoenix, Arizona, United States, 85008
2
Shriners Children's Northern California
Sacramento, California, United States, 95817
3
University of California Davis Health
Sacramento, California, United States, 95817
4
University of California San Diego
San Diego, California, United States, 92093