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NCT06131203 Clinical Trial

Burn Pivotal Study

Burns Clinical Trial

Official title:
Performance Evaluation of the DeepView AI-Burn For Assessment of Thermal Burn Healing Potential

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06131203
Other study ID # CLA-PR-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 19, 2023
Est. completion date March 2025

Study information
Verified date March 2024
Source SpectralMD
Contact Mary Regan, PhD
Phone (972) 499-4934
Email regan@spectralmd.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to validate the algorithm for burn healing assessment by the Spectral MD DeepView device which would provide burn healing potential assessment.

Recruitment information / eligibility
Status Recruiting
Enrollment 240
Est. completion date March 2025
Est. primary completion date January 2025
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 Akron Children's Hospital Akron Ohio
United States University of North Carolina Chapel Hill Chapel Hill North Carolina
United States University of Iowa Iowa City Iowa
United States St. Christopher's Children Hospital Philadelphia Pennsylvania
United States Valleywise Health Phoenix Arizona
United States Shriners Children's Northern California Sacramento California
United States University of California Davis Health Sacramento California
United States University of Washington Harborview Seattle Washington
United States SUNY Stony Brook Medical Center Stony Brook New York

Sponsors (1)
Lead Sponsor Collaborator
SpectralMD

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary BC Endpoint Demonstrate the DeepView AI-Burns' sensitivity is superior to BC HCPs' bedside examination while maintaining non-inferior specificity to burn HCPs. 3 weeks
See also
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