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Burn Pivotal Study

Sponsor
SpectralMD (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06131203
Collaborator
(none)
240
Enrollment
3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to validate the algorithm for burn healing assessment by the Spectral MD DeepView device which would provide burn healing potential assessment.

Condition or Disease Intervention/Treatment Phase
  • Device: DeepView SnapShot Portable (DV-SSP)

Study Design

Study Type:
Observational
Anticipated Enrollment :
240 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
PERFORMANCE EVALUATION OF THE DEEPVIEW AI-BURNS FOR ASSESSMENT OF THERMAL BURN HEALING POTENTIAL
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Emergency Department Burn Subjects

Subjects with Thermal Burn Injury enrolled through the emergency department

Device: DeepView SnapShot Portable (DV-SSP)
DV-SSP assistive imaging to collect observational data
Burn Center Burn Subjects

Subjects with Thermal Burn Injury enrolled through the burn center

Device: DeepView SnapShot Portable (DV-SSP)
DV-SSP assistive imaging to collect observational data

Outcome Measures

Primary Outcome Measures

  1. Primary BC Endpoint [3 weeks]

    Demonstrate the DeepView AI-Burns' sensitivity is superior to BC HCPs' bedside examination while maintaining non-inferior specificity to burn HCPs.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Willing 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; and Minimum burn wound size for adult or pediatric patients is 0.5% TBSA per region For adult Subjects: Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn.

For pediatric Subjects: Have 1 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn

Exclusion Criteria:

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; 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • SpectralMD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SpectralMD
ClinicalTrials.gov Identifier:
NCT06131203
Other Study ID Numbers:
  • CLA-PR-01
First Posted:
Nov 14, 2023
Last Update Posted:
Nov 14, 2023
Last Verified:
Nov 1, 2023
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
Additional relevant MeSH terms:
Wounds and Injuries
Burns

Study Results

No Results Posted as of Nov 14, 2023