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| Name | Class |
|---|---|
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd | UNKNOWN |
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Using liver biopsy as the gold standard, this study will conduct visual transient elastography (ViTE) examinations using Mindray Hepatus 9 ultrasound diagnostic system in patients with liver injury to evaluate the diagnostic efficacy of Liver Steatosis Analysis (LiSA) and ViTE for grading hepatic steatosis and fibrosis, and establish corresponding diagnostic thresholds.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual Transient Elastography (ViTE) Examination | Other | Post-marketing product (Mindray Hepatus 9 Ultrasound Diagnostic System) for visual transient elastography examination in patients with liver injury. |
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic performance of LiSA and ViTE was evaluated using the area under the receiver operating characteristic curve (AUROC). | Optimal cutoff values for LiSA and ViTE were determined by maximizing the Youden index, sensitivity (Se), and specificity (Sp). For each cutoff value, the following metrics with 95% confidence intervals (CI) were calculated: sensitivity (Se), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV). | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with liver injury
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Sun, PhD | Contact | 08613818676775 | csun7682@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200082 | China |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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