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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05023135
• Other study ID #: CT-2021-01--CSP-10
• Status: Completed
• Start date: September 7, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2024
• Source: SpectralMD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: April 30, 2023
• Est. primary completion date: April 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Burns
• Wound Heal

Intervention

Device:
• DeepView SnapShot Portable (DV-SSP)
DV-SSP assistive imaging to collect observational data

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
SpectralMD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predict area of severe burn, using measurement tools such as the Pearson Correlation Coefficient	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.	3 weeks