Burn Validation Study (BVS)

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

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Burns; Wound Heal
• Intervention / Treatment: Device: DeepView SnapShot Portable (DV-SSP)

• Study Type: Observational
• Enrollment (Actual): 274

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • ValleyWise Health
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Health
    • Sacramento, California, United States, 95817
      • Shriners Children's Northern California
    • San Diego, California, United States, 92093
      • University of California San Diego
  • District of Columbia
    • Washington DC, District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • University of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Stony Brook, New York, United States, 11794
      • SUNY Stony Brook Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina Chapel Hill
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19134
      • St. Christopher's Children Hospital
  • South Carolina
    • Charelston, South Carolina, United States, 29425
      • MUSC Shawn Jenkins Children's Hospital
  • Texas
    • Lubbock, Texas, United States, 79409
      • Texas Tech University
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health
  • Virginia
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Harborview

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects enrolled in this study will be recruited at the designated Study Site within 72 hours of suffering a thermal burn injury. Adult and pediatric Subjects with burns from one or more of the defined burn severities will be enrolled. All Subjects must meet the specified inclusion criteria.

Description

Inclusion Criteria:

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 Criteria:

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Emergency Department Burn Subjects; Subjects with Thermal Burn Injury enrolled through the emergency department	Device: DeepView SnapShot Portable (DV-SSP); DV-SSP assistive imaging to collect observational data
Burn Center Burn Subjects; Subjects with Thermal Burn Injury enrolled through the burn center	Device: DeepView SnapShot Portable (DV-SSP); DV-SSP assistive imaging to collect observational data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary BC Endpoint	Demonstrate the DeepView AI-Burns' sensitivity is superior to BC HCPs' bedside examination while maintaining non-inferior specificity to burn HCPs.	3 weeks

Collaborators and Investigators

• Sponsor: SpectralMD

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Actual): March 17, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: CLA-PR-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No