A Prospective Evaluation of Clinical Equivalence Between i:X and PID
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Concordance
研究概览
简要总结
Patients with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, a standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.
详细描述
Patients (n = 50) with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.
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
- •Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) of unknown infection status
- •18 years of age or older
排除标准
- •Treatment with an investigational drug within 1 month before study enrollment
- •Subjects with recent (<30 days) biopsy or curettage of target wound
- •Subjects with wounds that cannot be completely imaged by study device due to anatomic location
- •Unable or unwilling to consent
结局指标
主要结局
Concordance
时间窗: 2 months
The inter-reader concordance of the iX and PID FL-images together is not less than the inter-reader concordance of the iX FL-images alone.
次要结局
- Sensitivity and Specificity(2 months)