BurnsNCT05023135
DeepView SnapShot Portable (DV-SSP): Device Training Study
An observational study of Burns and Wound Heal, run by SpectralMD at 11 sites in United States.
Trial summary
The purpose of this study is to continue development and validation of an algorithm for burn healing assessment by the Spectral MD DeepView device and provide burn healing potential assessment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns, Wound Heal
- What is being tested?
- DeepView SnapShot Portable (DV-SSP)
- Type of treatment
- Medical device
- How many people
- 251 participants
- Where
- 11 sitesUnited States
- Study dates
- 7 Sep 2021to 30 Apr 2023
- 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
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Bridgeport Hospital
Bridgeport, Connecticut, 06610
University of South Carolina
Charleston, South Carolina, 29425
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Children's Hospital
New Orleans, Louisiana, 70118
St. Christopher's Childrens Hospital
Philadelphia, Pennsylvania, 19134
Valleywise Health
Phoenix, Arizona, 85008
Stony Brook Medicine
Stony Brook, New York, 11794
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The purpose of this study is to continue development and validation of an algorithm for burn healing assessment by the Spectral MD DeepView device and provide burn healing potential assessment.
- Conditions
- Burns, Wound Heal
- Being tested
- DeepView SnapShot Portable (DV-SSP)
- Medical subject headings
- Burns
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 |
|---|---|---|
| Subjects with Thermal Burn Injury | An initial imaging with the DV-SSP would be completed at the Study Site within 72 hours of suffering a thermal burn injury. Receives: Device: DeepView SnapShot Portable (DV-SSP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predict area of severe burn, using measurement tools such as the Pearson Correlation Coefficient
Test that the Burn Segmentation Algorithm's predicted severe burn area (i.e., deep second degree and third degree) within an image of a burn injury, will be equivalent to the true area of severe burn as determined by the expert panel. The analysis for this study would only include data obtained from participants in the study.
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 posted26 Aug 2021
- Study start7 Sep 2021
- Primary completion9 Apr 2023
- Study completion30 Apr 2023
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
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpectralMD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023135
- Sponsor's protocol ID
- CT-2021-01--CSP-10
- Status last verified
- Mar 2024
- First submitted
- 20 Aug 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DeepView SnapShot Portable (DV-SSP): Device Training Study
- ClinicalTrials.gov ID
- NCT05023135
- Acronym / sponsor ID
- CT-2021-01--CSP-10
- Conditions
- Burns, Wound Heal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- SpectralMDIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 9 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 26 Aug 2021 (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 continue development and validation of an algorithm for burn healing assessment by the Spectral MD DeepView device and provide burn healing potential assessment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Thermal Burn Injury | – | Device: DeepView SnapShot Portable (DV-SSP)An initial imaging with the DV-SSP would be completed at the Study Site within 72 hours of suffering a thermal burn injury. |
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 (7 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
Key exclusion criteria (6 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
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 | Subjects with Thermal Burn Injury |
Primary outcome
Predict area of severe burn, using measurement tools such as the Pearson Correlation Coefficient
Time frame: 3 weeks
Test that the Burn Segmentation Algorithm's predicted severe burn area (i.e., deep second degree and third degree) within an image of a burn injury, will be equivalent to the true area of severe burn as determined by the expert panel. The analysis for this study would only include data obtained from participants in the study.
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 6 Mar 2024.
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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.
11 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 11 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 7 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: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Predict area of severe burn, using measurement tools such as the Pearson Correlation Coefficient (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 6 Mar 2024.