BurnsUK HHFNCT07677657
Deepview HHF Training and Validation Study
An observational study of Burns and Burn Injury, run by SpectralMD.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns, Burn Injury, Diagnostic
- What is being tested?
- DeepView AI System
- Type of treatment
- Medical device
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2026to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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
- Minimum burn wound size for adult or paediatric participants is 0.25% TBSA per region
- Have burn(s) on the head, hands and/or feet that meet the criteria for a Study Burn. If multiple regions meet the Study Burn criteria, per the discretion of the Investigator, all Study Burn regions should be included.
Who cannot join
- 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
- Concurrent use of products such as chemical debriding agents, skin substitutes and others that the principal investigator deems will have an impact on the image quality and healing potential of a Study Burn
- Any condition that, in the opinion of the Investigator, may prevent compliance with the study requirements or compromise Participant safety
Show all 9Show fewer
- Participants without a burn on the hands, feet, head or neck, or burns located on these regions only on the palmar or plantar surfaces
- Chemical or any other non-thermal burns
- 8. Participants anticipated to or undergoing enzymatic debridemen9
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Taylor Frank contact
About this study
Official title: Deepview HHF Training and Validation Label Expansion Study
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.
- Conditions
- Burns, Burn Injury, Diagnostic
- Being tested
- DeepView AI System
- Medical subject headings
- Burns, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeepView AI SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: DeepView AI System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time of Injury through 21 Day Healing Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start5 Oct 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SpectralMD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677657
- Sponsor's protocol ID
- CLA-PR-12
- Acronym
- UK HHF
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deepview HHF Training and Validation Label Expansion Study
- ClinicalTrials.gov ID
- NCT07677657
- Acronym / sponsor ID
- UK HHF / CLA-PR-12
- Conditions
- Burns, Burn Injury, Diagnostic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- SpectralMDIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Thermal Burn Injury | – | Device: DeepView AI SystemAn initial imaging with the DV-SSP would be completed at the Study Site within 72 hours of suffering a thermal burn injury. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
- Minimum burn wound size for adult or paediatric participants is 0.25% TBSA per region
Key exclusion criteria (9 listed)
- 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
- Concurrent use of products such as chemical debriding agents, skin substitutes and others that the principal investigator deems will have an impact on the image quality and healing potential of a Study Burn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeepView AI SystemDeepView 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. | Device | Subjects with Thermal Burn Injury |
Primary outcome
Label Expansion Through Imaging HHF
Time frame: Time of Injury through 21 Day Healing Assessment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taylor Frank contact
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Burn Injury, run by SpectralMD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Krajcevska, MTM (972-499-4934, krajcevska@spectralmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Label Expansion Through Imaging HHF (time frame: Time of Injury through 21 Day Healing Assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.