DeepView Snapshot Handheld (DV-H) Comparison Study

NCT ID: NCT06024512

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-13
• Study Completion Date: 2024-01-25

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Interventions

Burn

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SpectralMD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LSU Health New Orleans University Medical Center New Orleans

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

CLA-PR-03

Identifier Type: -

Identifier Source: org_study_id