BurnNCT06938061
Utilizing 3D Imaging for Burn Wound Assessment
An observational study of Burn and 2nd Degree Burn of the Skin, run by HealthPartners Institute at 1 site in United States.
Trial summary
The goal of this prospective cohort study is to determine if the DermaMonitor camera can accurately determine burn size in patients with 1st, 2nd, or 3rd degree burns, with exploratory aim of testing a new Artificial Intelligence (AI) program for determining burn depth. The main aims are: 1. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Burn, 2nd Degree Burn of the Skin, 3rd Degree Burn of the Skin
- What is being tested?
- 3D Imaging
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2025to 3 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting outpatient to the Regions Hospital burn clinic after a burn
Who may be able to join
- Adults sustaining burns
- Outpatients
- No prior surgery on the wounds
- No known infection of the wounds
Who cannot join
- Burns to the face or sensitive areas (genitals)
- Burns located on or near identifying landmarks such as tattoos or birthmarks
- Non-English speaking patients
- Patients unable to sign their name
- Burn occurred greater than 7 days prior to clinic visit
- Age greater than 90 (Patient age is sent externally to IKO, to ensure no PHI is sent, patients with an age >90 will not be enrolled)
Trial locations and contacts
1 site in 1 country.
United States1 site
Regions Hospital Burn Clinic
Saint Paul, Minnesota, 55101
About this study
Official title: Integrating 3D Imaging Technology for Precise Burn Wound Assessment
The goal of this prospective cohort study is to determine if the DermaMonitor camera can accurately determine burn size in patients with 1st, 2nd, or 3rd degree burns, with exploratory aim of testing a new Artificial Intelligence (AI) program for determining burn depth. The main aims are:
- The primary aim of this study is to assess an objective process for the classification of burn size using the DermaMonitor wound camera.
- An exploratory aim of this study is to begin to train an Artificial Intelligence (AI) program to classify burn depth (1st, 2nd, 3rd degree) using the 3D images from this novel wound camera.
Researchers will compare DermaMonitor size classification and AI depth classification to clinician determinations. Participants will have images taken of their burn. Participation ends when the images are taken.
- Conditions
- Burn, 2nd Degree Burn of the Skin, 3rd Degree Burn of the Skin, 1st Degree Burn of the Skin
- Being tested
- 3D Imaging
- Keywords
- 3D Imaging, AI
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D ImagingDevice
Also called DermaMonitor Camera
The Derma Monitor device is a handheld, battery powered camera incorporating polarized LED illumination, a high-resolution CMOS color image sensor and a 3D depth sensor, allowing for the imaging and mapping of a patient's skin.
| Study group | Role | What they receive |
|---|---|---|
| 1st Degree Burn | Patients presenting to Regions Hospital Burn Clinic with a 1st degree burn Receives: Device: 3D Imaging | |
| 2nd Degree Burn | Patients presenting to Regions Hospital Burn Clinic with a 2nd degree burn Receives: Device: 3D Imaging | |
| 3rd Degree Burn | Patients presenting to Regions Hospital Burn Clinic with a 3rd degree burn Receives: Device: 3D Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between TBSA based on Clinician measurements and TBSA based on DermaMonitor Camera measurements
Measurements of the burn will be taken by clinicians in the burn clinic and translated into total burn surface area (TBSA) using body mass index and height. This will be compared to TBSA computed from measurements taken virtually using the DermaMonitor camera and the same body mass index and height values.
Measured: Through study completion, an average of one year
Secondary outcomes (1)
Concordance between clinician burn depth determination (1st, 2nd, 3rd degree burn) and AI determination of burn depth based on DermaMonitor images
Clinicians will subjectively determine burn depth (1st, 2nd, or 3rd degree) based on physical exam and clinical factors. This will be compared to burn depth assessment (1st, 2nd, or 3rd degree) made by an Artificial Intelligence program using the 3D images from the DermaMonitor camera.
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start20 May 2025
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Why it stopped: Stopped due to feasibility concerns with enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938061
- Sponsor's protocol ID
- A24-362
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Consent form does not explicitly approve sharing of data with external sources.
Publications
Irwin LR, Reid CA, McLean NR. Burns in children: do casualty officers get it right? Injury. 1993 Mar;24(3):187-8. doi: 10.1016/0020-1383(93)90291-d.
PubMed 8509192Ho HL, Halim AS, Sulaiman WAW, Fatimah MJ. Estimation of Total Body Surface Area Burned: A Comparison Between Burn Unit and Referring Facilities. Ann Burns Fire Disasters. 2023 Mar 31;36(1):19-28. eCollection 2023 Mar.
PubMed 38680901
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating 3D Imaging Technology for Precise Burn Wound Assessment
- ClinicalTrials.gov ID
- NCT06938061
- Acronym / sponsor ID
- A24-362
- Conditions
- Burn, 2nd Degree Burn of the Skin, 3rd Degree Burn of the Skin, 1st Degree Burn of the Skin
- Keywords
- 3D Imaging, AI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Stopped due to feasibility concerns with enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 22 Apr 2025 (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 goal of this prospective cohort study is to determine if the DermaMonitor camera can accurately determine burn size in patients with 1st, 2nd, or 3rd degree burns, with exploratory aim of testing a new Artificial Intelligence (AI) program for determining burn depth. The main aims are:
- The primary aim of this study is to assess an objective process for the classification of burn size using the DermaMonitor wound camera.
- An exploratory aim of this study is to begin to train an Artificial Intelligence (AI) program to classify burn depth (1st, 2nd, 3rd degree) using the 3D images from this novel wound camera.
Researchers will compare DermaMonitor size classification and AI depth classification to clinician determinations. Participants will have images taken of their burn. Participation ends when the images are taken.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1st Degree Burn | – | Device: 3D ImagingPatients presenting to Regions Hospital Burn Clinic with a 1st degree burn |
| 2nd Degree Burn | – | Device: 3D ImagingPatients presenting to Regions Hospital Burn Clinic with a 2nd degree burn |
| 3rd Degree Burn | – | Device: 3D ImagingPatients presenting to Regions Hospital Burn Clinic with a 3rd degree burn |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting outpatient to the Regions Hospital burn clinic after a burn
Key inclusion criteria (4 listed)
- Adults sustaining burns
- Outpatients
- No prior surgery on the wounds
- No known infection of the wounds
Key exclusion criteria (6 listed)
- Burns to the face or sensitive areas (genitals)
- Burns located on or near identifying landmarks such as tattoos or birthmarks
- Non-English speaking patients
- Patients unable to sign their name
- Burn occurred greater than 7 days prior to clinic visit
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 |
|---|---|---|
| 3D ImagingAlso: DermaMonitor CameraThe Derma Monitor device is a handheld, battery powered camera incorporating polarized LED illumination, a high-resolution CMOS color image sensor and a 3D depth sensor, allowing for the imaging and mapping of a patient's skin. | Device | 1st Degree Burn, 2nd Degree Burn, 3rd Degree Burn |
Primary outcome
Concordance between TBSA based on Clinician measurements and TBSA based on DermaMonitor Camera measurements
Time frame: Through study completion, an average of one year
Measurements of the burn will be taken by clinicians in the burn clinic and translated into total burn surface area (TBSA) using body mass index and height. This will be compared to TBSA computed from measurements taken virtually using the DermaMonitor camera and the same body mass index and height values.
1 secondary outcome
Concordance between clinician burn depth determination (1st, 2nd, 3rd degree burn) and AI determination of burn depth based on DermaMonitor images
Time frame: Through study completion, an average of one year
Results and safety
The study was stopped early (reason given: Stopped due to feasibility concerns with enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 8509192Irwin LR, Reid CA, McLean NR. Burns in children: do casualty officers get it right? Injury. 1993 Mar;24(3):187-8. doi: 10.1016/0020-1383(93)90291-d.
- Background: PubMed 38680901Ho HL, Halim AS, Sulaiman WAW, Fatimah MJ. Estimation of Total Body Surface Area Burned: A Comparison Between Burn Unit and Referring Facilities. Ann Burns Fire Disasters. 2023 Mar 31;36(1):19-28. eCollection 2023 Mar.
- Individual participant dataSharing planned: No. Consent form does not explicitly approve sharing of data with external sources.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn and 2nd Degree Burn of the Skin, run by HealthPartners Institute at 1 site in United States.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Stopped due to feasibility concerns with enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between TBSA based on Clinician measurements and TBSA based on DermaMonitor Camera measurements (time frame: Through study completion, an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06938061, which also lists 2 linked publications.
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 3 Jun 2026.