跳至主要内容
临床试验/NCT06921421
NCT06921421尚未招募不适用

Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging (SFDI): An Observational Pilot Study

The Metis Foundation1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年4月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
Mean SFDI Scattering Parameter (mm-¹) at Burn Injury Sites Using Clarifi and m-Clarifi Imaging Systems

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients 18 years of age or older
  • •Thermal burns of any depth (superficial, deep partial thickness, or full thickness).

排除标准

  • •Patients less than 18 years of age
  • •Pregnant or breastfeeding women

结局指标

主要结局

Mean SFDI Scattering Parameter (mm-¹) at Burn Injury Sites Using Clarifi and m-Clarifi Imaging Systems

时间窗: 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.

次要结局

  • Correlation Between SFDI Scattering Parameter and Clinician-Determined Burn Depth(From enrollment to 21 days)

研究者

发起方
The Metis Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodney Chan

Principal Investigator

The Metis Foundation

研究点 (1)

Loading locations...

相似试验