DeepView Snapshot Handheld (DV-H) Comparison Study

NCT06024512 | Completed FDA Device

• 1 other identifier: CLA-PR-03
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SpectralMD: lead

Study Sites (1)

LSU Health New Orleans University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 6, 2023
• Study Start: June 13, 2023
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: April 16, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1 year

Locations

US (1)