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Burn Validation Study | Clinical Trials | Clareo Health

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Burn Validation Study

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

NCT06131203•SpectralMD

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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.

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 D.C., 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

Key Dates

Start Date

December 19, 2023

Primary Completion Date

March 17, 2025

Completion Date

April 1, 2025

Last Updated

April 25, 2025

Enrollment

274

ACTUAL participants

Conditions

BurnsWound HealWounds and Injuries

Interventions

DeepView SnapShot Portable (DV-SSP)

DEVICE

Machine Learning for Handheld Vascular Studies

NCT02932176

AtherosclerosisWounds and Injuries

View study

RECRUITINGPHASE2

4-Aminopyridine to Treat Skin Burns

NCT06596434

BurnsSecond Degree Burn+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Burn Validation Study

Inclusion Criteria

Exclusion Criteria

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