NCT02358213已完成不适用
Evaluation of the Reproducibility Inter-observer of the Ultrasound Anomalies of the Salivary Glands in Sjogren's Disease : Etude ETREINTE.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Reproducibility between experts
研究概览
简要总结
This aim of this study is to compare the reproducibility of reading of five international experts concerning the anomalies of the salivary glands.
The reproducibility is measure on patients and not on recorded data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women from 18 to 80 years old
- •Patients recruited during the multidisciplinary consultation of Sjogren's Disease, filling the criteria of Sjogren's Disease or patients having a salivary recidivate pathology and selected players on the basis of their voluntary service to benefit from an ultrasound of the main salivary glands
- •The patients will have to be capable of adhering to the protocol of study and of having understood it.
- •The patients will have to be capable of giving a signed informed consent, the latter being obtained before the inclusion
排除标准
- •Not cooperative patient and having refused to sign the informed consent.
- •Patient incapable to understand the protocol, under guardianship or under guardianship.
- •Unaffiliated patients to the Social Security.
结局指标
主要结局
Reproducibility between experts
时间窗: 1 day
The outcome measure will be assessed bythe answer of a questionnaire which will be complete by the 5 international experts.
次要结局
- Reproducibility by the sonographer(1 day)
研究者
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