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

Spectral MD

Status: Completed

Conditions: Burns

Treatments: Device: Burn

Study type: Observational

Funder types: Industry

Identifiers

NCT06024512

CLA-PR-03

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.