Deepview HHF Training and Validation Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSpectralMD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to give informed consent, have a witnessed verbal consent, family discussion if intubated and retrospective consent for those that are intubated
Life expectancy > 1 month
Thermal burn mechanism (flame, scald, or contact)
The Study Burn(s) occurred less than 72 hours prior to the time of first imaging
Disqualifiers
Sepsis at the time of enrolment
Infection of the burn wound at the time of enrolment
Immunosuppression / radiation / chemotherapy < 3 months prior to enrolment
Concurrent use of investigational products with a known effect on the burn sites; and/or imaging
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
DeepView AI System
DeviceDeepView 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.
Treatment groups
280 Participants
are divided into 1 treatment groupGroup A: Subjects with Thermal Burn Injury1 intervention
Trial outcomes
Primary outcomes
1
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 frame
Time of Injury through 21 Day Healing AssessmentLocations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: