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NCT06921421 · ClinicalTrials.gov registry record
Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging
A clinical trial, sponsored by The Metis Foundation.
- Not yet
- Registry status
- 15
- Enrollment target
NCT06921421: Clinical Trial study, sponsored by The Metis Foundation.
NCT06921421 is a clinical trial that has not yet begun recruiting, run by The Metis Foundation. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06921421 has not yet begun recruiting, sponsored by The Metis Foundation.
- NOT YET RECRUITING
- Registry status
- 15 participants
- Enrollment target
Study 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. 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).
Primary Outcome
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.
Interventions
- DIAGNOSTIC_TEST Spatial Frequency Domain Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-04 |
| Est. Completion | 2025-12 |
What is known before NCT06921421 opens enrollment
NCT06921421 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Spatial Frequency Domain Imaging is the first listed.
NCT06921421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06921421 about?
NCT06921421 is a clinical study titled "Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging". 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...
What is the current status of trial NCT06921421?
This trial is currently not yet recruiting. The enrollment target is 15 participants. The study started on 2025-04. Estimated completion is 2025-12.
What interventions are being tested in trial NCT06921421?
The interventions under investigation include: Spatial Frequency Domain Imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06921421?
This trial is sponsored by The Metis Foundation, which has 8 total clinical trials registered on ClinicalTrials.gov.
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