M149 - Development of a FibroScan Liver Examination Using a Single Probe
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Echosens
- 入组人数
- 389
- 试验地点
- 4
- 主要终点
- Difference between LSM by guided-VCTE performed with the single probe and LSM by guided-VCTE performed with the reference probes (M and XL).
研究概览
简要总结
This is an exploratory, international, prospective, interventional, multicenter clinical investigation that will take place in 1 Hong Kong site and 3 French sites and 309 adults patients will be included. The study objective is to assess the LSM reproducibility between the FibroScan examination performed with the Single Probe (SP) and the FibroScan examination performed with the reference probes (M and XL).
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
- 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
- •Adult patients (≥ 18 years of age).
- •Patient followed with a chronic liver disease.
- •Adult patient able to give his written consent.
- •For European sites: patient affiliated to the healthcare system.
排除标准
- •Vulnerable patients.
- •Patients with ascites.
- •Patients with heart failure.
- •Patients with acute hepatitis.
- •Patients with biliary obstruction.
研究组 & 干预措施
All patients
Adult patients followed in the Hepatology department for a chronic liver disease, all etiologies combined.
干预措施: Research FibroScan (Device)
结局指标
主要结局
Difference between LSM by guided-VCTE performed with the single probe and LSM by guided-VCTE performed with the reference probes (M and XL).
时间窗: At Day 0
This outcome assesses the difference between the values of LSM obtained with the single probe and the reference probes (M and XL) when performed in the same patients.
次要结局
- To assess the LSM and CAP repeatability of FS with the SP and FS with the reference probe (M+ and XL+)(At day 0)
- Difference between CAP performed with single probe and CAP performed with the reference probes (M and XL).(At Day 0)
- Difference of patient percentage having a successful examination between the FibroScan (guided-VCTE) examination performed with the single probe and the FibroScan (guided-VCTE) examination performed with the reference FibroScan probes (M and XL probes).(At Day 0)
- Difference between the values reported by the patient on the comfort scale after a FibroScan (guided-VCTE) examination performed with the single probe and after a FibroScan examination (guided-VCTE) performed with the reference probes (M and XL).(At Day 0)