Burn Validation Study

NCT ID: NCT06131203

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

274 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-19

Study Completion Date

2025-04-01

Brief Summary

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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

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Conditions

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Burns Wound Heal Wounds and Injuries

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Emergency Department Burn Subjects

Subjects with Thermal Burn Injury enrolled through the emergency department

DeepView SnapShot Portable (DV-SSP)

Intervention Type DEVICE

DV-SSP assistive imaging to collect observational data

Burn Center Burn Subjects

Subjects with Thermal Burn Injury enrolled through the burn center

DeepView SnapShot Portable (DV-SSP)

Intervention Type DEVICE

DV-SSP assistive imaging to collect observational data

Interventions

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DeepView SnapShot Portable (DV-SSP)

DV-SSP assistive imaging to collect observational data

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SpectralMD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Valleywise Health

Phoenix, Arizona, United States

Site Status

Shriners Children's Northern California

Sacramento, California, United States

Site Status

University of California Davis Health

Sacramento, California, United States

Site Status

University of California San Diego

San Diego, California, United States

Site Status

MedStar Washington Hospital Center

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

Site Status

Tampa General Hospital

Tampa, Florida, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

University Medical Center

New Orleans, Louisiana, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

SUNY Stony Brook Medical Center

Stony Brook, New York, United States

Site Status

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Akron Children's Hospital

Akron, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

St. Christopher's Children Hospital

Philadelphia, Pennsylvania, United States

Site Status

MUSC Shawn Jenkins Children's Hospital

Charelston, South Carolina, United States

Site Status

Texas Tech University

Lubbock, Texas, United States

Site Status

University of Utah Health

Salt Lake City, Utah, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

University of Washington Harborview

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CLA-PR-01

Identifier Type: -

Identifier Source: org_study_id

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