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Completed

NCT Number: NCT05023135

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

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.

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Key information

Conditions

Burns Wound Heal Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DeepView SnapShot Portable (DV-SSP)

Device

DV-SSP assistive imaging to collect observational data

Primary outcomes

  1. Predict area of severe burn, using measurement tools such as the Pearson Correlation Coefficient

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

SpectralMD

Industry

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2021
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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