CTRI/2024/08/072422
Not yet recruiting
Phase 4
Diagnostic performance of quantitative ultrasound parameters in assessing hepatic steatosis in NAFLD with MRI PDFF as the reference standard a prospective non randomized cohort study - NI
Samsung Medison Co.Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: E785- Hyperlipidemia, unspecified
- Sponsor
- Samsung Medison Co.Ltd
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who clinically suspected MASLD based on EASL–EASD–EASO Clinical Practice
- •Guidelines for the management of Metabolic Dysfunction\-Associated Steatotic Liver Disease
- •(MASLD), or patients who recommended to undergo either abdominal ultrasound
- •examination or liver MRI examination
- •2\. Male or Female of Age \=18 years ,
- •3\. Individuals who have decided to participate in the clinical study on their own will and have
- •provided the informed consent after reading/hearing and fully understanding the detailed explanations regarding the clinical study.
Exclusion Criteria
- •1\. Subject who has disagreed the signing of informed consent form for this study
- •2\. Subject who has a history of chronic liver disease due to etiology other than MASLD.
- •3\. Subject who had a daily alcohol consumption ?30 g for men and ?20 g for women based on
- •EASL– ASD–EASO Clinical Practice Guidelines for the management of metabolic dysfunction associated steatotic liver disease (MASLD)
- •4\. Subject who has a history of long\-term use of hepatotoxic drugs.
- •5\. Subject with acute liver failure
- •6\. Subject who has a history of esophageal varix, hydrops abdominis, hepatic coma, as well as
- •patents with signs of acute biliary obstruction, or those who had recent liver surgery.
- •7\. Woman who is pregnant
Outcomes
Primary Outcomes
Not specified
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