LivQ-box® Parameters in the Diagnosis of Liver Inflammation

Wuxi Hisky Medical Technology

Status: Enrolling

Conditions: Liver Inflammation; Fatty Liver Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06802731

HSKE-LI001

Details and patient eligibility

About

To evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels.

Full description

This study is a multi-center study that retrospectively analyzed and prospectively included 240 NAFLD patients in total who met the inclusion criteria. The laboratory, iLivTouch, and liver biopsy results were collected to evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels. In the end, cut-off values for different stages of inflammation were obtained.

Enrollment: 365 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients diagnosed with NAFLD according to The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases;
• Age over 18 years old, gender not limited;
• Not combined with liver diseases (such as viral hepatitis, drug-induced liver injury, autoimmune liver disease);
• Perform iLivTouch examination within ± 14 days of liver pathology examination;
• No history of excessive alcohol consumption (converted to ethanol:<140g/week for males,<70g/week for females);