Validation of a Medical Device, a Mobile Spectrofluorimeter, Measuring Skin Autofluorescence in Healthy Volunteers. (PHOTOFLUO)
Validation of a Medical Device, a Mobile Spectrofluorimeter, Measuring Skin Autofluorescence in Healthy Volunteers
The Institut has developed a spectrofluorimeter for the registration and monitoring of skin autofluorescence.
This Spectrofluorometer must be initially validated in healthy volunteers. In the long term, it will be used clinically to measure residual photosensitivity of patients who received a photosensitizer in photodynamic therapy.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Vandoeuvre-lès-Nancy、法国、54500
- Institut de Cancérologie de Lorraine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Man and woman over 18 yers old
- Women of childbearing age under contraceptive
- Healthy volunteers able and willing to follow all procedures of the agreement with the study protocol.
- Healthy volunteers affiliated to the social security
- Ability to provide written informed consent
- Patient's legal capacity to consent to study participation
Exclusion Criteria:
- Healthy volunteers with scars or open wounds on the palms
- Healthy volunteers with warts on their hands
- Healthy volunteers with blister on their hands
- Healthy volunteers involved in another clinical trial
- Pregnant or breastfeeding women
- People in emergencies
- Deprived of liberty or under supervision
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Healthy volunteers
Healthy volunteers wash their hands with a traditional soap. Every healthy volunteers pose with palm of hand three times on the device in order to measure basal level of fluorescence of the skin. Healthy volunteers repeated three times this procedure in order to assess the reproducibility of the measurement. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intraindividual reproducibility of measuring the natural and basal skin fluorescence
大体时间：1 day
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The intra-individual reproducibility of measurement of natural and basal skin fluorescence will be evaluated on a healthy volunteers using a mobile spectrofluorimeter.
The value of intra-class correlation coefficient will be measured by the method of Fleiss (Fleiss, 1986).
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1 day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Demographic parameter
大体时间：1 day
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gender
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1 day
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Concomitant treatments
大体时间：1 day
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Concomitant treatments ( anti-inflammatory antihistaminic, antifungal...) influencing the natural and basal skin fluorescence will be listed.
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1 day
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Dominant hand
大体时间：1 day
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left hand / right hand
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1 day
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合作者和调查者
调查人员
- 首席研究员：Guillemin François, MD, PUPH、Institut de Cancérologie de Lorraine
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2014-A01220-47
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
mobile spectrofluorimeter的临床试验
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Klein Buendel, Inc.National Institute on Minority Health and Health Disparities (NIMHD); Pennington Biomedical...完全的
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Environment and Health Group, Inc.Prisma Health完全的
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The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)撤销
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VA Office of Research and Development尚未招聘
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Medical College of WisconsinChildren's National Research Institute终止