Development of Predictive Indicators of Homogeneous Propagation of Ultrasound and Elastic Waves During VCTE Examination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Echosens
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Validity criteria of the Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE) (automatically assessed by the Reference and the Research FibroScan)
研究概览
简要总结
This is an European, prospective, interventional, and multicenter exploratory clinical investigation that will take place in 6 French sites and 200 patients will be included (adults and children). The study objective is to develop predictive indicators of homogeneous propagation of ultrasound and elastic waves to define an optimal region of interest for the measurement of liver stiffness during VCTE examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult and pediatric patients, all etiologies combined
- •Patient must be able to give written informed consent, or the parents in the case of a minor patient
- •Patient affiliated to a social security system
排除标准
- •Vulnerable patient- other than pediatric patients
- •Pregnant or breastfeeding woman
结局指标
主要结局
Validity criteria of the Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE) (automatically assessed by the Reference and the Research FibroScan)
时间窗: 7 months
The validity criteria is an analysis of the measurement, automatically computed by the FibroScan. A measurement analyzed as "valid" leads to a reliable LSM whereas a measurement analyzed as "invalid" leads to a non-reliable LSM.
次要结局
- Calculate the bias between the PCD measured by the VCTE (Reference FibroScan) and the PCD measured by the VGTE (Research FibroScan).(7 months)
- The bias between the CAPc measured with the VCTE (Reference FibroScan) and the CAPc measured by the Vibration Guided Transient Elastography (VGTE) (Research FibroScan).(7 months)