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TerminatedNCT06938061Updated Jun 3, 2026

Utilizing 3D Imaging for Burn Wound Assessment

An observational study in Burn, 2nd Degree Burn of the Skin and 3rd Degree Burn of the Skin, sponsored by HealthPartners Institute. Terminated at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by HealthPartners Institute · Observational

Why this study was terminated
Stopped due to feasibility concerns with enrollment
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
8
Ages
18 Years to 89 Years
Sex
All
01

Study 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. The primary aim of this study is to assess an objective process for the classification of burn size using the DermaMonitor wound camera.
  2. 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.

02

Conditions studied

  • Burn
  • 2nd Degree Burn of the Skin
  • 3rd Degree Burn of the Skin
  • 1st Degree Burn of the Skin

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Keywords

  • 3D Imaging
  • AI
03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's enrollment of 8 is below the median of 55 across 135 observational studies indexed under Burns.

Browse Burns studies →

Lead sponsor

HealthPartners Institute is the lead sponsor of 164 studies on the registry; 20 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients presenting outpatient to the Regions Hospital burn clinic after a burn

Inclusion criteria

  • Adults sustaining burns
  • Outpatients
  • No prior surgery on the wounds
  • No known infection of the wounds

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
8 participants (actual)
Patient registry
No

Groups and cohorts

  • 1st Degree Burn

    Patients presenting to Regions Hospital Burn Clinic with a 1st degree burn

    Device: 3D Imaging

  • 2nd Degree Burn

    Patients presenting to Regions Hospital Burn Clinic with a 2nd degree burn

    Device: 3D Imaging

  • 3rd Degree Burn

    Patients presenting to Regions Hospital Burn Clinic with a 3rd degree burn

    Device: 3D Imaging

Interventions

  • Device3D Imaging

    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.

    Also known as: DermaMonitor Camera

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Through study completion, an average of one year

07

Study locations

1 site
  • Regions Hospital Burn Clinic
    Saint Paul, Minnesota 55101, United States
08

References and documents

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 8509192 ↗
  • Ho 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 ↗

Individual participant data

Plan to share: No — Consent form does not explicitly approve sharing of data with external sources.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06938061
Lead sponsor
HealthPartners Institute
Responsible party
Sponsor
First posted
Apr 22, 2025
Start date
May 20, 2025
Primary completion
Mar 3, 2026
Completion
Mar 3, 2026
Last update
Jun 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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