Burn Validation Study

NCT06131203 | Completed FDA Device

• 1 other identifier: CLA-PR-01
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 21

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.

Conditions

Burns; Wound Heal; Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Emergency Department Burn Subjects

Subjects with Thermal Burn Injury enrolled through the emergency department

Device: DeepView SnapShot Portable (DV-SSP)

Burn Center Burn Subjects

Subjects with Thermal Burn Injury enrolled through the burn center

Device: DeepView SnapShot Portable (DV-SSP)

Interventions

DeepView SnapShot Portable (DV-SSP) DEVICE

DV-SSP assistive imaging to collect observational data

Burn Center Burn Subjects; Emergency Department Burn Subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify 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 may not qualify 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.

Sponsors & Collaborators

• SpectralMD: lead

Study Sites (21)

Valleywise Health

Phoenix, Arizona, 85008, United States

Location

Shriners Children's Northern California

Sacramento, California, 95817, United States

Location

University of California Davis Health

Sacramento, California, 95817, United States

Location

University of California San Diego

San Diego, California, 92093, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University Medical Center

New Orleans, Louisiana, 70112, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

SUNY Stony Brook Medical Center

Stony Brook, New York, 11794, United States

Location

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

St. Christopher's Children Hospital

Philadelphia, Pennsylvania, 19134, United States

Location

MUSC Shawn Jenkins Children's Hospital

Charelston, South Carolina, 29425, United States

Location

Texas Tech University

Lubbock, Texas, 79409, United States

Location

University of Utah Health

Salt Lake City, Utah, 84132, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

University of Washington Harborview

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Burns; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 14, 2023
• Study Start: December 19, 2023
• Primary Completion: March 17, 2025
• Study Completion: April 1, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

US (21)