Assessment of Hepatic Steatosis Using Dedicated Software Implemented on Ultrasound Devices
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Fondazione IRCCS Policlinico San Matteo di Pavia
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Comparison of the results relating to the degree of steatosis detected by the various ultrasound devices with the CAP module
概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease, with an estimated prevalence of 5-30% in the general population and 55-80% in patients with type 2 diabetes.
Methods for the quantitative and non-invasive assessment of liver fat content have recently been implemented on ultrasound devices, based on the estimation of the ultrasound beam attenuation coefficient and backscattering. These methods are CE marked and already commercially available.
The aim of the study is to compare the results of the degree of steatosis detected by different ultrasound devices with the degree of steatosis of the CAP (Controlled Attenuation Parameter) module implemented on the Fibroscan machine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age \> 18 years,
- •ability to hold breath for image acquisition,
- •informed consent
排除标准
- •withdrawal of informed consent,
- •any condition which, in the clinical judgement of the investigator, will make further participation in the study unacceptable for that individual patient
结局指标
主要结局
Comparison of the results relating to the degree of steatosis detected by the various ultrasound devices with the CAP module
时间窗: 05 May 2025
次要结局
未报告次要终点
研究者
Gianluigi Poma
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia