Burn Validation Study
- Conditions
- Wounds and InjuriesBurnsWound Heal
- Interventions
- Device: DeepView SnapShot Portable (DV-SSP)
- Registration Number
- NCT06131203
- Lead Sponsor
- SpectralMD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
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
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Emergency Department Burn Subjects DeepView SnapShot Portable (DV-SSP) Subjects with Thermal Burn Injury enrolled through the emergency department Burn Center Burn Subjects DeepView SnapShot Portable (DV-SSP) Subjects with Thermal Burn Injury enrolled through the burn center
- Primary Outcome Measures
Name Time Method Primary BC Endpoint 3 weeks Demonstrate the DeepView AI-Burns' sensitivity is superior to BC HCPs' bedside examination while maintaining non-inferior specificity to burn HCPs.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Valleywise Health
🇺🇸Phoenix, Arizona, United States
Shriners Children's Northern California
🇺🇸Sacramento, California, United States
University of California Davis Health
🇺🇸Sacramento, California, United States
University of California San Diego
🇺🇸San Diego, California, United States
MedStar Washington Hospital Center
🇺🇸Washington DC, District of Columbia, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
University Medical Center
🇺🇸New Orleans, Louisiana, United States
University of Rochester
🇺🇸Rochester, New York, United States
SUNY Stony Brook Medical Center
🇺🇸Stony Brook, New York, United States
University of North Carolina Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
St. Christopher's Children Hospital
🇺🇸Philadelphia, Pennsylvania, United States
MUSC Shawn Jenkins Children's Hospital
🇺🇸Charelston, South Carolina, United States
Texas Tech University
🇺🇸Lubbock, Texas, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Washington Harborview
🇺🇸Seattle, Washington, United States