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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05023135
Other study ID # CT-2021-01--CSP-10
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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