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

Spectral MD

Status: Completed

Conditions: Wound Heal; Burns

Treatments: Device: DeepView SnapShot Portable (DV-SSP)

Study type: Observational

Funder types: Industry

Identifiers

NCT05023135

CT-2021-01--CSP-10

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: All

Volunteers: No 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.

Trial design

251 participants in 1 patient group

Subjects with Thermal Burn Injury

Description:

An initial imaging with the DV-SSP would be completed at the Study Site within 72 hours of suffering a thermal burn injury.

Treatment:

Device: DeepView SnapShot Portable (DV-SSP)