LivQ-box® Parameters in the Diagnosis of Liver Inflammation

NCT ID: NCT06802731

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 365 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-06-30

Brief Summary

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.

Detailed 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.

Conditions

Liver Inflammation; Fatty Liver Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility 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);

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Changgeng Hospital

OTHER

Sponsor Role: collaborator

Wuxi Hisky Medical Technology Co Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tsinghua Changgung Hospital (BTCH) affiliated to Tsinghua University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lai Wei

Role: CONTACT

weilai@pkuph.edu.cn

+86 13601281862

Facility Contacts

Lai Wei

Role: primary

weilai@pkuph.edu.cn

13601281862

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Other Identifiers

HSKE-LI001

Identifier Type: -

Identifier Source: org_study_id