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

Completed

• Conditions: Burns; Wound Heal
• Interventions: Device: DeepView SnapShot Portable (DV-SSP)

• Registration Number: NCT05023135
• Lead Sponsor: SpectralMD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-26
• Study Start: 2021-09-07
• Primary Completion: 2023-04-09
• Study Completion: 2023-04-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with Thermal Burn Injury	DeepView SnapShot Portable (DV-SSP)	An initial imaging with the DV-SSP would be completed at the Study Site within 72 hours of suffering a thermal burn injury.

Primary Outcome Measures

Name	Time	Method
Predict area of severe burn, using measurement tools such as the Pearson Correlation Coefficient	3 weeks	Test that the Burn Segmentation Algorithm's predicted severe burn area (i.e., deep second degree and third degree) within an image of a burn injury, will be equivalent to the true area of severe burn as determined by the expert panel. The analysis for this study would only include data obtained from participants in the study.

Trial Locations

Locations (11)

University Medical Center New Orleans; 🇺🇸 New Orleans, Louisiana, United States

St. Christopher's Childrens Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Stony Brook Medicine; 🇺🇸 Stony Brook, New York, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Children's Hospital; 🇺🇸 New Orleans, Louisiana, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States

MedStar Health Research Institute; 🇺🇸 Washington, District of Columbia, United States

Valleywise Health; 🇺🇸 Phoenix, Arizona, United States

University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States