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The purpose of this Study is to help expand the use of the DeepView AI System so that it can assess burn injuries on the hands, head/face, and feet. To do this, the Study will collect new images of burns in these areas. Some of these images will be used to improve and retrain the AI system, while others will be used to test how well the updated system performs. The images for both purposes will be collected at the same time. The new images from the hands, head/face, and feet will then be combined with existing images from other body areas. This will allow researchers to determine whether the updated AI system performs as well as, or better than, previous versions of the technology. For participants with Study Burns requiring surgical excision, the Study site clinician will collect punch biopsies from the Study Burn according to a standardised burn wound punch biopsy collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Thermal Burn Injury | An initial imaging with the DV-SSP would be completed at the Study Site within 72 hours of suffering a thermal burn injury. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DeepView AI System | Device | DeepView is an assistive imaging device which will be used to collect observational data as part of the study. The device will be blinded and only used for data collection. |
| Measure | Description | Time Frame |
|---|---|---|
| Label Expansion Through Imaging HHF | The number of Hand, Head, Feet (HHF) images collected with the DeepView AI System (DV) is the primary objective of this study in order to support the expansion of the intended use of the DV System. These images are used to assess the ground truth using a panel of expert burn surgeons. | Time of Injury through 21 Day Healing Assessment |
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Inclusion Criteria:
Exclusion Criteria:
8. Participants anticipated to or undergoing enzymatic debridemen9
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Subjects enrolled in this study will be recruited at the designated Study Site within 72 hours of suffering a thermal burn injury. Adult and pediatric Subjects with burns from one or more of the defined burn severities will be enrolled. All Subjects must meet the specified inclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Krajcevska, MTM | Contact | 972-499-4934 | krajcevska@spectralmd.com | |
| Taylor Frank | Contact | frank@spectralmd.com |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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