DeepView Snapshot Handheld (DV-H) Comparison Study

his study is being done to collect pictures of burns using an investigational device called the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected will be used to assess the performance of the DV-H device, and to determine the device's ability to differentiate healing versus non-healing burn tissue. This device, if approved, is expected to give caregivers a better understanding of what parts of burn wounds will likely not heal on their own and as a tool used by the military in the field. This current study involves the collection of images over the course of your clinical treatment and follow-up according to your routine standard of care. The device will not be used to diagnose or prescribe treatment for your burn

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Key information

Conditions

Burns Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

LSU Health New Orleans University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Who can participate

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

Inclusion criteria

.Age >18 years 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;
Minimum burn wound size for patients is 0.5% TBSA per region
Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn; and

Exclusion criteria

Patients will be excluded if any of the following conditions apply:

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 determined by diagnosis made by Principal Investigator or Sub-Investigator;
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

Burn

Device

This study is being done to collect pictures of burns using an investigational device called the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected will be used to assess the performance of the DV-H device, and to determine the device's ability to differentiate healing versus non-healing burn tissue. This device, if approved, is expected to give caregivers a better understanding of what parts of burn wounds will likely not heal on their own and as a tool used by the military in the field. This current study involves the collection of images over the course of your clinical treatment and follow-up according to your routine standard of care. The device will not be used to diagnose or prescribe treatment for your burn.

Primary outcomes

DeepView Snapshot Handheld (DV-SSH) Comparison Study Protocol

Time frame: 3 months

The primary objective of this study is to demonstrate that the proposed SA-MSI sensor is equivalent or better than the current LC-MSI sensor.

To conduct this test, we will compare the performance of the burn assessment AI algorithm using the image sensor as input data to the same Algorithm using the lens cluster data as an input.

Sponsors and collaborators

Lead sponsor

SpectralMD

Industry

Registry information

Acronym: DHA

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Sep 6, 2023
Registry last updated: Apr 16, 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.

Published trials that share one or more normalized conditions with this study.

Completed