Evaluation of Diagnostic Performances of a New Point-of-care Ultrasound System for the Detection of Fibrotic NASH and the Assessment of Liver Disease Severity in Patients With Known or Suspected Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 主要终点
- Diagnostic performance estimates
研究概览
简要总结
The main objective of the study is to determine the diagnostic performances of an ultraportable diagnostic ultrasound system for the assessment of liver fibrosis severity in patients with NASH, and to compare them to other non-invasive tests.
详细描述
This is a prospective cross-sectional study that will recruit approximately 1000 patients across 30 clinical sites in Europe and the USA.
The target recruited population will include adult patients at risk of, or with known chronic liver diseases, whether or not screened for inclusion in NASH pharmaceutical trials.
After being informed about the study objectives and potential risks, patients who consent to participate will undergo an non-invasive external ultrasound exam of their liver using an ultraportable diagnostic ultrasound system. The system will derive quantitative information related to physical and acoustic properties of the liver tissue, which are known to correlate with the severity of chronic diffuse liver diseases such as fibrosis and steatosis.
The study will also assess the repeatability, reproducibility and robustness of quantitative parameters. Collected data will also enable exploring ultrasound-based liver tissue characterization correlated to NASH-specific histological lesions such as intra-hepatic inflammation and hepatic cell ballooning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Any of the following criteria:
- •Patients with known chronic liver diseases referred to liver-specific exams by their referring physician as part of the routine practice, including a VCTE exam, with or without a blood test, a MRI/MRE exam, a liver biopsy,
- •Patients screened for fibrotic NASH in the context of NASH pharmaceutical trials, for which a data sharing agreement has been signed between E-Scopics and the pharmaceutical trial promoter,
- •Patients who consent in written to participate in the Clinical Investigation after being orally informed on the objectives and methods of the Clinical Investigation,
- •European patients covered by a social security program
排除标准
- •Patients under 18 years of age or over 80 years of age,
- •Patients with active implants such as pacemakers, defibrillators, pumps, etc.
- •Patients presenting wounds at the location where the ES1 probe shall be placed on patients' skin,
- •Adult patients under social tutorship, or unable to provide informed consent when not subject to tutorship measures,
- •Pregnant and breastfeeding women,
- •People deprived of their freedom rights
- •People who have been hospitalized without giving informed consent or under emergency situation,
- •People admitted in a social or sanitary institution for other reasons than the Clinical Investigation,
- •Patients included in another research study that could interfere with the present Clinical Investigation.
结局指标
主要结局
Diagnostic performance estimates
时间窗: At study completion, 1 year
Estimates of diagnostic performances at a defined cutoff, for binary diagnostic objectives (detect ≥ F2, ≥ F3, or F4): 1. Sensitivity, specificity, and diagnostic accuracy 2. Positive and negative predictive values
Elastography diagnostic performance
时间窗: At study completion, 1 year
Differences between areas under ROC curves for the ES1 liver stiffness measurement, used as a diagnostic measure of liver fibrosis severity, and other methods, in NASH patients.
次要结局
- Liver stiffness robustness indicators(At study completion, 1 year)
- Equivalence with other methods(At study completion, 1 year)