Summary

Location
at San Diego, California and other locations
Dates
study started
completion around
Principal Investigator
by Jeanne Lee, MD
Headshot of Jeanne Lee
Jeanne Lee

Description

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.

Official Title

Performance Evaluation of the DeepView AI-Burn For Assessment of Thermal Burn Healing Potential

Keywords

Burns, Wound Heal, Wounds and Injuries, DeepView SnapShot Portable (DV-SSP)

Eligibility

You can join if…

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

You CAN'T join if...

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.

Locations

  • University of California San Diego not yet accepting patients
    San Diego California 92093 United States
  • Valleywise Health in progress, not accepting new patients
    Phoenix Arizona 85008 United States
  • University of California Davis Health accepting new patients
    Sacramento California 95817 United States
  • Texas Tech University accepting new patients
    Lubbock Texas 79409 United States

Lead Scientist at UCSD

  • Jeanne Lee, MD
    Clinical Professor, Surgery, Vc-health Sciences-schools. Authored (or co-authored) 13 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
SpectralMD
ID
NCT06131203
Study Type
Observational
Participants
Expecting 240 study participants
Last Updated