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AI learns to see burns on hands, head, and feet

NCT ID NCT07677657

Diagnosis Sponsor: SpectralMD Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Oct 08, 2026 · Updated 3 times

Summary

This study tests an AI-powered imaging device called DeepView to see if it can accurately assess burn injuries on the hands, head, and feet. Researchers will collect images from people with burns in these areas to train and improve the AI system. The goal is to help doctors make faster, more precise decisions about burn treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DeepView AI System (imaging device)
What this could lead to
If successful, this AI system could help doctors quickly and accurately assess burn severity on hands, head, and feet, guiding better treatment decisions.
What could go wrong
This is an early-stage study focused on data collection and AI training, not a treatment. The AI may not perform as well as expected in real-world settings.
Why investors are watching

SpectralMD, part of micro-cap Spectral AI, Inc., is running a 280-participant study to expand its DeepView AI System beyond its current uses so it can assess burn injuries on the hands, head or face, and feet. Researchers collect new images of burns in these areas, use some to retrain the AI and others to test the updated version, then combine them with existing images from other body areas to compare performance against earlier versions. For a company this small, a readout on whether the expanded system works as well as or better than before is a central test of how broadly the product can be used.

If it works: If the updated system performs as well as or better than earlier versions, Spectral AI could point to a wider set of body areas the DeepView AI System can assess, which may support broader clinical adoption.

If it fails: If the updated system performs worse than earlier versions, or if image collection and biopsy work at the sites falls behind, the label expansion could stall. Clinical studies of this kind often fail or take longer than planned.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to give informed consent, have a witnessed verbal consent, family discussion if intubated and retrospective consent for those that are intubated 2. Life expectancy \> 1 month 3. Thermal burn mechanism (flame, scald, or contact) 4. The Study Burn(s) occurred less than 72 hours prior to the time of first imaging 5. Minimum burn wound size for adult or paediatric participants is 0.25% TBSA per region 6. 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. Exclusion Criteria: 1. Sepsis at the time of enrolment 2. Infection of the burn wound at the time of enrolment 3. Immunosuppression / radiation / chemotherapy \< 3 months prior to enrolment 4. Concurrent use of investigational products with a known effect on the burn sites; and/or imaging 5. 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 6. Any condition that, in the opinion of the Investigator, may prevent compliance with the study requirements or compromise Participant safety 7. Participants without a burn on the hands, feet, head or neck, or burns located on these regions only on the palmar or plantar surfaces 8. Chemical or any other non-thermal burns 8\. Participants anticipated to or undergoing enzymatic debridemen9

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Conditions

The condition(s) this trial relates to.

burn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Burn injury Burns Diagnostic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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