Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US: A Multicenter, Cross-sectional, and Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 418
- 试验地点
- 4
- 主要终点
- Liver Stiffness Measurement (LSM) value from iLivTouch and FibroScan detection
研究概览
简要总结
This is a multi-center, cross-sectional, and prospective study that will recruit patients from multiple hospitals or outpatient clinics in the USA to the comparison of iLivTouch and FibroScan for the assessment of liver fibrosis and steatosis in adult patients.
详细描述
Clinical phase: Phase IV investigator-initiated study Study centers planned: Approximately 4 centers in different regions of the USA
Objectives:
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Primary Objectives To evaluate the consistency of Liver Stiffness Measurement (LSM) and Ultrasound/Controlled Attenuation Parameters (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices.
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Secondary Objectives
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To compare the operational features of the two devices, reflected in the success rate of examination and number of effective examinations.
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To compare LSM obtained from each device with liver stiffness estimated by APRI, FIB-4, and SAFE scores.
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The number of adverse events, serious events, and percentage of subjects with events will be calculated for AE, SAE, AE of special interest, and AE leading to study withdrawal.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •a. Adults aged above 18 years old who have at least one indication for TE examination determined by the physicians;
- •b. Patients who have test results for platelet count, ALT, AST, globulin, HBA1c, and total bilirubin (TBIL) levels within 60 days;
- •c. Patients who are willing to participate in the clinical study and can sign ICF.
排除标准
- •a. Excessive drinking history within 90 days: For women-140 grams of alcohol per week or more; For men-210 grams of alcohol per week or more;
- •b. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase AST >100 U/ml (or 2.5 × upper limit of normal (ULN) and/or total bilirubin (TBIL) > 1.8 mg/d (or >1.5 × ULN =1.2 mg/d);
- •c. Patients with a history or current evidence of decompensated liver cirrhosis;
- •d. Patients with various space-occupying tumors and cysts in the right liver;
- •e. Patients with other serious systemically diseases or a history of malignant tumors;
- •f. Patients with ascites;
- •g. Patients with a non-healing wound on the right upper abdomen at this moment;
- •h. Patients with intracavitary implantation of instruments;
- •i. Pregnant women (urine pregnancy test should be performed for all women with child-bearing potential during screening);
- •j. Any history of organ transplantation and existing functional grafts (except corneal or hair transplantation);
- •k. Lack of or limited legal capacity.
结局指标
主要结局
Liver Stiffness Measurement (LSM) value from iLivTouch and FibroScan detection
时间窗: 6 months
Spearman correlation coefficients and 95% confidence interval will be calculated to analyze the correlation of the measurements (LSM) between iLivTouch-FT9000 and FibroScan 530 devices.
Ultrasound/Controlled Attenuation Parameters (UAP/CAP) from iLivTouch and FibroScan detection
时间窗: 6 months
Spearman correlation coefficients and 95% confidence interval will be calculated to analyze the correlation of the measurements (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices.
次要结局
- Liver stiffness measurement (LSM) and Steatosis-associated Fibrosis Estimator (SAFE) scores(6 months)
- Liver stiffness measurement (LSM) and AST to Platelet Ratio Index (APRI)(6 months)
- To compare the success rate of the iLivTouch and FibroScan(6 months)
- Adverse events, serious events(6 months)
- To compare the number of effective examinations of iLivTouch and FibroScan(6 months)
- Liver stiffness measurement (LSM) and Fibrosis-4 (FIB-4)(6 months)