Status:
COMPLETED
DeepView Snapshot Handheld (DV-H) Comparison Study
Lead Sponsor:
SpectralMD
Conditions:
Burns
Eligibility:
All Genders
18-75 years
Brief Summary
his study is being done to collect pictures of burns using an investigational device called the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected will be used to ...
Eligibility Criteria
Inclusion
- .Age \>18 years 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;
- Minimum burn wound size for patients is 0.5% TBSA per region
- Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn; and
Exclusion
- Patients will be excluded if any of the following conditions apply:
- 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 determined by diagnosis made by Principal Investigator or Sub-Investigator;
- 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 :
June 13 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 25 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06024512
Start Date
June 13 2023
End Date
January 25 2024
Last Update
April 16 2024
Active Locations (1)
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1
LSU Health New Orleans University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112