DeepView SnapShot Portable (DV-SSP): Device Training Study

Completed

Conditions studied: Burns, Wound Heal

In brief

The purpose of this study is to continue development and validation of an algorithm for burn healing assessment by the Spectral MD DeepView device and provide burn healing potential assessment.

Key facts

Study ID

NCT05023135

Run by

SpectralMD

People needed

251

Starts

2021-09-07

Expected to finish

2023-04-30

Last updated by the study team

2024-03-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Valleywise Health — Phoenix, Arizona, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• MedStar Health Research Institute — Washington D.C., District of Columbia, United States
• University Medical Center New Orleans — New Orleans, Louisiana, United States
• Children's Hospital — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Stony Brook Medicine — Stony Brook, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• St. Christopher's Childrens Hospital — Philadelphia, Pennsylvania, United States
• University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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