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| Name | Class |
|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Guangzhou First People's Hospital | OTHER |
| Ruijin Hospital | OTHER |
This will be a multi-center, prospective, controlled study. It is expected that about 240 subjects from 10 study centers will be enrolled, and 224 effective subjects will be statistically analyzed in the end, in which 56 effective subjects with stage F0 (25%), 56 effective subjects with stage F1 (25%), 56 effective subjects with stage F2 (25%), 56 effective subjects with stage F3 (25%). By comparison of the result of FibroTouch examination with that of liver biopsy, their specificities, sensitivities and accuracies for diagnosis of liver steatosis will be identified.
The patients with liver diseases who need to have a liver biopsy in hospital and meet all of the inclusion criteria and none of the exclusion criteria, may participate in this study. Within two weeks of FibroTouch examination, subjects are required to have qualified histological specimens of liver biopsy for comparation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F0 | Liver Steatosis Grade: <5% |
| |
| F1 | Liver Steatosis Grade: 5-33% |
| |
| F2 | Liver Steatosis Grade: 34-66% |
| |
| F3 | Liver Steatosis Grade: > 66% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FibroTouch | Device |
| ||
| Liver Biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| The coincidence for diagnosis of hepatic steatosis between fat attenuation parameter (FAP) of FibroTouch and liver biopsy by ROC analysis | Performance of fat attenuation parameter (FAP, dB/m) of FibroTouch will be assessed using ROC analysis for the detection of hepatic steatosis stage F0 (<5%), stage F1 (5%-33%), stage F2 (34%-66%), and stage F3 (2>66%) using liver biopsy as the reference. | Within two weeks of FibroTouch examination |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects with liver diseases who need to have a liver biopsy in hospital and meet all of the inclusion criteria and none of the exclusion criteria, may participate in this study. Within two weeks of FibroTouch examination, subjects are required to have qualified histological specimens of liver biopsy for comparation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng LU, Bachelor | Contact | +86-10-62701872 | lupeng@fibrotouch.com | |
| Bo WANG, Bachelor | Contact | +86-10-62701872 | wangbo@fibrotouch.com |
| Name | Affiliation | Role |
|---|---|---|
| Lungen LU, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital | Recruiting | Chengdu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33848277 | Derived | Qu Y, Song YY, Chen CW, Fu QC, Shi JP, Xu Y, Xie Q, Yang YF, Zhou YJ, Li LP, Xu MY, Cai XB, Zhang QD, Yu H, Fan JG, Lu LG. Diagnostic Performance of FibroTouch Ultrasound Attenuation Parameter and Liver Stiffness Measurement in Assessing Hepatic Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Clin Transl Gastroenterol. 2021 Apr 13;12(4):e00323. doi: 10.14309/ctg.0000000000000323. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 1, 2022 | |
| Reset | Mar 14, 2023 | |
| Release | Oct 11, 2023 |
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| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
| OTHER |
| No.85 Hospital, Changning, Shanghai, China | OTHER |
| The Second Hospital of Nanjing Medical University | OTHER |
| Sichuan Academy of Medical Sciences | OTHER |
| Second People's Hospital of Hangzhou | UNKNOWN |
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Liver Biospy Specimens
| Procedure |
|
| Guangzhou First Municipal People's Hospital | Recruiting | Guangzhou | China |
|
| Second People's Hospital of Hangzhou | Recruiting | Hangzhou | China |
|
| The Second Hospital Of Nanjing | Recruiting | Nanjing | China |
|
| Ruijin Hospital | Recruiting | Shanghai | China |
|
| Shanghai 85 Hospital | Recruiting | Shanghai | China |
|
| Shanghai First People's Hospital | Recruiting | Shanghai | China |
|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
|
| Reset | Apr 11, 2024 |
| Release | Feb 13, 2025 |
| Reset | Mar 5, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 1, 2022 | Mar 14, 2023 | |||
| Oct 11, 2023 | Apr 11, 2024 | |||
| Feb 13, 2025 | Mar 5, 2025 |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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