Optimization of Spleen VCTE Examinations with FibroScan
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Echosens
- 入组人数
- 433
- 试验地点
- 4
- 主要终点
- Success rate of the spleen stiffness measurement (SSM) exam with both the optimized M+ probe and the exploratory XL+ probe, defined with at least 8 valid measurements after the exam quality control
研究概览
简要总结
This is an European, prospective, interventional, and multicenter clinical investigation which main objective is to develop a spleen examination dedicated to overweight or obese patients and assess its applicability. It will take place in 4 sites (1 site in the Netherlands, 2 sites in Spain and 1 site in Romania) to include a total of 500 patients (adults and children).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult or pediatric patient able to give written informed consent (parents/legal tutors in case of minor patients),
- •Patient affiliated to the healthcare system
- •Adult or children patient followed for a liver disease a suspicion of liver disease or for a consequence of a liver disease, with or without splenomegaly and having a spleen to skin distance (SSD) measurement performed during the screening ultrasound exam.
排除标准
- •Vulnerable patient- other than pediatric patients
- •Patients with ascites
结局指标
主要结局
Success rate of the spleen stiffness measurement (SSM) exam with both the optimized M+ probe and the exploratory XL+ probe, defined with at least 8 valid measurements after the exam quality control
时间窗: At baseline visit
The success rate is calculated with the number of valid measurements vs the total measurements done by the operator for every exam. The FibroScan will automatically analyze the measurement and based on some validity criteria will define the measurement as "valid" (will lead to a reliable SSM measurement) or "invalid" (will lead to a non-reliable SSM measurement).
次要结局
- Success rate of the spleen stiffness measurement (SSM) exam with the S probe, defined with at least 8 valid measurements after the exam quality control.(At baseline visit)
- Change of the applicability with the Spleen Targeting Tool (STT) and the automatic depth adaptation mode enabled.(At baseline visit)
- Success rate of the spleen stiffness measurement (SSM) exam with the optimized M probe, defined with at least 8 valid measurements after the exam quality control.(At baseline visit)