BurnsBVSNCT06131203
Burn Validation Study
An observational study of Burns and Wound Heal, run by SpectralMD at 21 sites in United States.
Trial summary
The purpose of this study is to validate the algorithm for burn healing assessment by the Spectral MD DeepView device which would provide burn healing potential assessment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns, Wound Heal, Wounds and Injuries
- What is being tested?
- DeepView SnapShot Portable (DV-SSP)
- Type of treatment
- Medical device
- How many people
- 274 participants
- Where
- 21 sitesUnited States
- Study dates
- 19 Dec 2023to 1 Apr 2025
- 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 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 or have a Legally Authorized Representative (LAR) able to do so; Life expectancy > 6 months; Thermal burn mechanism (flame, scald, or contact); The Study Burn(s) occurred less than 72 hours prior to the time of first imaging; and Minimum burn wound size for adult or pediatric patients is 0.5% TBSA per region For adult Subjects: Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn.
- For pediatric Subjects: Have 1 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn
Who cannot join
- Burn pattern distribution isolated to head, face, neck, hands, feet, genitalia, and/or joints; Subject has burns involving > 50% total body surface area (TBSA); Sepsis at the time of enrollment; Immunosuppression/radiation/chemotherapy < 3 months prior to enrollment; Concurrent use of investigational products with a known effect on the burn sites; and/or Any condition that in the opinion of the Investigator may prevent compliance with the study requirements or compromise subject safety.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Akron Children's Hospital
Akron, Ohio, 44308
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27514
MUSC Shawn Jenkins Children's Hospital
Charelston, South Carolina, 29425
Ohio State University
Columbus, Ohio, 43210
University of Iowa
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66103
University of Louisville
Louisville, Kentucky, 40202
Texas Tech University
Lubbock, Texas, 79409
University Medical Center
New Orleans, Louisiana, 70112
St. Christopher's Children Hospital
Philadelphia, Pennsylvania, 19134
Valleywise Health
Phoenix, Arizona, 85008
Virginia Commonwealth University
Richmond, Virginia, 23284
University of Rochester
Rochester, New York, 14642
Shriners Children's Northern California
Sacramento, California, 95817
University of California Davis Health
Sacramento, California, 95817
University of Utah Health
Salt Lake City, Utah, 84132
University of California San Diego
San Diego, California, 92093
University of Washington Harborview
Seattle, Washington, 98104
SUNY Stony Brook Medical Center
Stony Brook, New York, 11794
Tampa General Hospital
Tampa, Florida, 33606
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Performance Evaluation of the DeepView AI-Burn For Assessment of Thermal Burn Healing Potential
The purpose of this study is to validate the algorithm for burn healing assessment by the Spectral MD DeepView device which would provide burn healing potential assessment.
- Conditions
- Burns, Wound Heal, Wounds and Injuries
- Being tested
- DeepView SnapShot Portable (DV-SSP)
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeepView SnapShot Portable (DV-SSP)Device
DV-SSP assistive imaging to collect observational data
| Study group | Role | What they receive |
|---|---|---|
| Emergency Department Burn Subjects | Subjects with Thermal Burn Injury enrolled through the emergency department Receives: Device: DeepView SnapShot Portable (DV-SSP) | |
| Burn Center Burn Subjects | Subjects with Thermal Burn Injury enrolled through the burn center Receives: Device: DeepView SnapShot Portable (DV-SSP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary BC Endpoint
Demonstrate the DeepView AI-Burns' sensitivity is superior to BC HCPs' bedside examination while maintaining non-inferior specificity to burn HCPs.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start19 Dec 2023
- Primary completion17 Mar 2025
- Study completion1 Apr 2025
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
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpectralMD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131203
- Sponsor's protocol ID
- CLA-PR-01
- Acronym
- BVS
- Status last verified
- Apr 2025
- First submitted
- 8 Nov 2023
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the DeepView AI-Burn For Assessment of Thermal Burn Healing Potential
- ClinicalTrials.gov ID
- NCT06131203
- Acronym / sponsor ID
- BVS / CLA-PR-01
- Conditions
- Burns, Wound Heal, Wounds and Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- SpectralMDIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 14 Nov 2023 (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 validate the algorithm for burn healing assessment by the Spectral MD DeepView device which would provide burn healing potential assessment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency Department Burn Subjects | – | Device: DeepView SnapShot Portable (DV-SSP)Subjects with Thermal Burn Injury enrolled through the emergency department |
| Burn Center Burn Subjects | – | Device: DeepView SnapShot Portable (DV-SSP)Subjects with Thermal Burn Injury enrolled through the burn center |
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 (2 listed)
- Willing and able to give informed consent or have a Legally Authorized Representative (LAR) able to do so; Life expectancy > 6 months; Thermal burn mechanism (flame, scald, or contact); The Study Burn(s) occurred less than 72 hours prior to the time of first imaging; and Minimum burn wound size for adult or pediatric patients is 0.5% TBSA per region For adult Subjects: Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn.
- For pediatric Subjects: Have 1 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn
Key exclusion criteria (1 listed)
- Burn pattern distribution isolated to head, face, neck, hands, feet, genitalia, and/or joints; Subject has burns involving > 50% total body surface area (TBSA); Sepsis at the time of enrollment; Immunosuppression/radiation/chemotherapy < 3 months prior to enrollment; Concurrent use of investigational products with a known effect on the burn sites; and/or Any condition that in the opinion of the Investigator may prevent compliance with the study requirements or compromise subject safety.
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 SnapShot Portable (DV-SSP)DV-SSP assistive imaging to collect observational data | Device | Burn Center Burn Subjects, Emergency Department Burn Subjects |
Primary outcome
Primary BC Endpoint
Time frame: 3 weeks
Demonstrate the DeepView AI-Burns' sensitivity is superior to BC HCPs' bedside examination while maintaining non-inferior specificity to burn HCPs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
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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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Wound Heal, run by SpectralMD at 21 sites 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 1 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: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary BC Endpoint (time frame: 3 weeks). 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 25 Apr 2025.