BurnNCT06921421
Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging
An observational study of Burn and Burn Injury, run by The Metis Foundation at 1 site in United States.
Trial summary
The goal of this pilot clinical study is to evaluate the feasibility of collecting Spatial Frequency Domain Imaging (SFDI) data in patients with circulatory compromise due to thermal burns using the FDA-cleared Clarifi Imaging System and the next generation handheld m-Clarifi. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn, Burn Injury
- What is being tested?
- Spatial Frequency Domain Imaging
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2025to Oct 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving care at the US Army Institute of Surgical Research (USAISR) Burn Center with thermal burn injuries will be considered for enrollment into this study
Who may be able to join
- Patients 18 years of age or older
- Thermal burns of any depth (superficial, deep partial thickness, or full thickness).
Who cannot join
- Patients less than 18 years of age
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
The United States Army Institute of Surgical Resarch
Fort Sam Houston, Texas, 78234
About this study
Official title: Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging (SFDI): An Observational Pilot Study
The goal of this pilot clinical study is to evaluate the feasibility of collecting Spatial Frequency Domain Imaging (SFDI) data in patients with circulatory compromise due to thermal burns using the FDA-cleared Clarifi Imaging System and the next generation handheld m-Clarifi. Accurate assessment of burn depth and assessment at the point of care is an essential input for clinicians to plan proper treatment and management. SFDI has been shown to be a promising method to evaluate burn depth and extent within 24 hours in pre-clinical studies. The two feasibility goals of this study are as follows: 1) Do the values obtained with a commercial SFDI system provide utility in assessing burn depth in a clinical setting? And 2) Do Clarifi and m-Clarifi provide equivalent data when assessing subjects with burn injuries (biomarker imaging values, clinical workflow).
- Conditions
- Burn, Burn Injury
- Being tested
- Spatial Frequency Domain Imaging
- Keywords
- SFDI, Spatial Frequency Domain Imaging, Burn depth, Burn injury assessment
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial Frequency Domain ImagingDiagnostic test
Spatial Frequency Domain Imaging captures at specific timepoints.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean SFDI Scattering Parameter (mm-¹) at Burn Injury Sites Using Clarifi and m-Clarifi Imaging Systems
This outcome will report the mean value of the scattering coefficient (μs'), a quantitative SFDI-derived biomarker that correlates with burn depth, measured at specified time points (Day 0, 3, 7, 14, and 21) using the Clarifi and m-Clarifi imaging systems. Higher scattering values are associated with deeper tissue damage.
Measured: From enrollment to 21 days
Secondary outcomes (1)
Correlation Between SFDI Scattering Parameter and Clinician-Determined Burn Depth
This outcome evaluates the statistical correlation between SFDI scattering values and the burn depth classifications made by clinicians based on visual assessment and standard clinical criteria (e.g., superficial partial, deep partial, full thickness).
Measured: From enrollment to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start3 Jun 2025
- Primary completion10 Apr 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Metis Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- United States Army Institute of Surgical Research, Modulated Imaging Inc.
- Responsible party
- Sponsor
- Investigators
- Rodney Chan, MD, Principal investigator, The Metis Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921421
- Sponsor's protocol ID
- H-25-017
- Other IDs
- MTEC-22-08-BDA-007
- Status last verified
- Oct 2026
- First submitted
- 7 Mar 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging (SFDI): An Observational Pilot Study
- ClinicalTrials.gov ID
- NCT06921421
- Acronym / sponsor ID
- H-25-017
- Conditions
- Burn, Burn Injury
- Keywords
- SFDI, Spatial Frequency Domain Imaging, Burn depth, Burn injury assessment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Metis FoundationUniversity, hospital or other
- Collaborators
- United States Army Institute of Surgical Research, Modulated Imaging Inc.
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 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 pilot clinical study is to evaluate the feasibility of collecting Spatial Frequency Domain Imaging (SFDI) data in patients with circulatory compromise due to thermal burns using the FDA-cleared Clarifi Imaging System and the next generation handheld m-Clarifi. Accurate assessment of burn depth and assessment at the point of care is an essential input for clinicians to plan proper treatment and management. SFDI has been shown to be a promising method to evaluate burn depth and extent within 24 hours in pre-clinical studies. The two feasibility goals of this study are as follows: 1) Do the values obtained with a commercial SFDI system provide utility in assessing burn depth in a clinical setting? And 2) Do Clarifi and m-Clarifi provide equivalent data when assessing subjects with burn injuries (biomarker imaging values, clinical workflow).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving care at the US Army Institute of Surgical Research (USAISR) Burn Center with thermal burn injuries will be considered for enrollment into this study
Key inclusion criteria (2 listed)
- Patients 18 years of age or older
- Thermal burns of any depth (superficial, deep partial thickness, or full thickness).
Key exclusion criteria (2 listed)
- Patients less than 18 years of age
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Spatial Frequency Domain ImagingSpatial Frequency Domain Imaging captures at specific timepoints. | Diagnostic test | – |
Primary outcome
Mean SFDI Scattering Parameter (mm-¹) at Burn Injury Sites Using Clarifi and m-Clarifi Imaging Systems
Time frame: From enrollment to 21 days
This outcome will report the mean value of the scattering coefficient (μs'), a quantitative SFDI-derived biomarker that correlates with burn depth, measured at specified time points (Day 0, 3, 7, 14, and 21) using the Clarifi and m-Clarifi imaging systems. Higher scattering values are associated with deeper tissue damage.
1 secondary outcome
Correlation Between SFDI Scattering Parameter and Clinician-Determined Burn Depth
Time frame: From enrollment to 21 days
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 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Rodney Chan, MD principal investigator
The Metis Foundation
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 Burn Injury, run by The Metis Foundation 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 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?
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?
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?
Mean SFDI Scattering Parameter (mm-¹) at Burn Injury Sites Using Clarifi and m-Clarifi Imaging Systems (time frame: From enrollment to 21 days). 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 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.