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The sponsor withdrew from the study
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| Name | Class |
|---|---|
| ENDRA Life Sciences, Inc. | UNKNOWN |
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The study will evaluate the accuracy of hepatic steatosis estimation by thermo-acoustic ultrasound with estimation by MRI-PDFF (Proton Density Fat Fraction) . It will also evaluate the sensitivity of this device in the diagnosis of fatty liver.
Patients with either known or presumed diagnosis of non-alcoholic fatty liver disease who meets eligibility criteria will be included in the study. They will have imaging done to estimate hepatic steatosis by two modalities (MRI - PDFF and thermo-acoustic ultrasound). The estimation obtained by thermo-acoustic ultrasound will be compared with MRI results for accuracy of estimation by the thermo-acoustic ultrasound device. The study will also evaluate the sensitivity of the thermo-acoustic ultrasound device if it can diagnose the presence of hepatic steatosis when hepatic fat content is 15% or less by volume.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | The hepatic fat estimation will be performed on the same subjects with the use of the thermo-acoustic device and by MRI-PDFF. The data obtained from the two estimations will be compared. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermo-acuostic image acquisition of liver | Diagnostic Test | Estimation of hepatic fat content with thermo-acoustic device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of hepatic fat estimation by the thermo-acoustic device with MRI-PDFF technique | The study evaluates if the new thermo-acoustic device can accurately estimate the hepatic fat content among patients with non-alcoholic fatty liver disease to the currently approved method using MRI-PDFF scan. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the best and ideal number of the anatomical site for thermo-acoustic evaluation of liver | The study evaluates the number of estimation required and the appropriate anatomical site to evaluate the liver to obtain best results | One year |
| Evaluate the sensitivity of the thermo-acoustic device in the diagnosis of hepatic steatosis. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult volunteers with diagnosed or suspected for non-alcoholic fatty liver disease will be recruited in the study. Patients who meet inclusion and exclusion criteria will be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| ACHUTHAN SOURIANARAYANANE, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| MRI-PDFF estimation of hepatic fat | Diagnostic Test | Estimation of hepatic fat content with MRI |
|
Evaluate the sensitivity of the thermo-acoustic device in diagnosis presence of hepatic steatosis among patients with MRI-PDFF finding of more than 15% hepatic steatosis |
| One year |