BurnsDHANCT06024512
DeepView Snapshot Handheld (DV-H) Comparison Study
An observational study of Burns, run by SpectralMD at 1 site in United States.
Trial summary
his study is being done to collect pictures of burns using an investigational device called the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected will be used to assess the performance of the DV-H device, and to determine the device's ability to differentiate healing versus… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Burns
- What is being tested?
- Burn
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2023to 25 Jan 2024
- 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 75 years
- All sexes
- Adult, Older adult
Study population: The goal of this prospective study is to evaluate Study Burns from up to 22 Subjects. Adult will be defined as Subjects 18 years of age or older.
Who may be able to join
- .Age >18 years 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;
- Minimum burn wound size for patients is 0.5% TBSA per region
- Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn; and
Who cannot join
- Patients will be excluded if any of the following conditions apply:
- 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 determined by diagnosis made by Principal Investigator or Sub-Investigator;
- 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
1 site in 1 country.
United States1 site
LSU Health New Orleans University Medical Center New Orleans
New Orleans, Louisiana, 70112
About this study
his study is being done to collect pictures of burns using an investigational device called the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected will be used to assess the performance of the DV-H device, and to determine the device's ability to differentiate healing versus non-healing burn tissue. This device, if approved, is expected to give caregivers a better understanding of what parts of burn wounds will likely not heal on their own and as a tool used by the military in the field. This current study involves the collection of images over the course of your clinical treatment and follow-up according to your routine standard of care. The device will not be used to diagnose or prescribe treatment for your burn
- Conditions
- Burns
- Being tested
- Burn
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BurnDevice
This study is being done to collect pictures of burns using an investigational device called the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected will be used to assess the performance of the DV-H device, and to determine the device's ability to differentiate healing versus non-healing burn tissue. This device, if approved, is expected to give caregivers a better understanding of what parts of burn wounds will likely not heal on their own and as a tool used by the military in the field. This current study involves the collection of images over the course of your clinical treatment and follow-up according to your routine standard of care. The device will not be used to diagnose or prescribe treatment for your burn.
What is being measured
The primary outcome is the main question the study is designed to answer.
DeepView Snapshot Handheld (DV-SSH) Comparison Study Protocol
The primary objective of this study is to demonstrate that the proposed SA-MSI sensor is equivalent or better than the current LC-MSI sensor.
To conduct this test, we will compare the performance of the burn assessment AI algorithm using the image sensor as input data to the same Algorithm using the lens cluster data as an input.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start13 Jun 2023
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
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 only
- Time perspective
- Other
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpectralMD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024512
- Sponsor's protocol ID
- CLA-PR-03
- Acronym
- DHA
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Plan is still in motion.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DeepView Snapshot Handheld (DV-H) Comparison Study
- ClinicalTrials.gov ID
- NCT06024512
- Acronym / sponsor ID
- DHA / CLA-PR-03
- Conditions
- Burns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- SpectralMDIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 6 Sep 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.
his study is being done to collect pictures of burns using an investigational device called the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected will be used to assess the performance of the DV-H device, and to determine the device's ability to differentiate healing versus non-healing burn tissue. This device, if approved, is expected to give caregivers a better understanding of what parts of burn wounds will likely not heal on their own and as a tool used by the military in the field. This current study involves the collection of images over the course of your clinical treatment and follow-up according to your routine standard of care. The device will not be used to diagnose or prescribe treatment for your burn
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The goal of this prospective study is to evaluate Study Burns from up to 22 Subjects. Adult will be defined as Subjects 18 years of age or older.
Key inclusion criteria (6 listed)
- .Age >18 years 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;
- Minimum burn wound size for patients is 0.5% TBSA per region
Key exclusion criteria (7 listed)
- Patients will be excluded if any of the following conditions apply:
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 |
|---|---|---|
| BurnThis study is being done to collect pictures of burns using an investigational device called the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected will be used to assess the performance of the DV-H device, and to determine the device's ability to differentiate healing versus non-healing burn tissue. This device, if approved, is expected to give caregivers a better understanding of what parts of burn wounds will likely not heal on their own and as a tool used by the military in the field. This current study involves the collection of images over the course of your clinical treatment and follow-up according to your routine standard of care. The device will not be used to diagnose or prescribe treatment for your burn. | Device | – |
Primary outcome
DeepView Snapshot Handheld (DV-SSH) Comparison Study Protocol
Time frame: 3 months
The primary objective of this study is to demonstrate that the proposed SA-MSI sensor is equivalent or better than the current LC-MSI sensor. To conduct this test, we will compare the performance of the burn assessment AI algorithm using the image sensor as input data to the same Algorithm using the lens cluster data as an input.
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 16 Apr 2024.
- Individual participant dataSharing planned: Yes. Plan is still in motion.
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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 Burns, run by SpectralMD 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 6 inclusion and 7 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 16 Apr 2024. 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 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?
DeepView Snapshot Handheld (DV-SSH) Comparison Study Protocol (time frame: 3 months). 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 16 Apr 2024.