DeepView Snapshot Handheld (DV-H) Comparison Study (DHA)

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

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Device: Burn

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • LSU Health New Orleans University Medical Center New Orleans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The goal of this prospective study is to evaluate Study Burns from up to 22 Subjects. Adult will be defined as Subjects 18 years of age or older.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DeepView Snapshot Handheld (DV-SSH) Comparison Study Protocol	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.	3 months

Collaborators and Investigators

• Sponsor: SpectralMD

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2023
• Primary Completion (Actual): January 25, 2024
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CLA-PR-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan is still in motion.
• IPD Sharing Time Frame: 1 year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No