Evaluating LivQ-box® for diagnosing liver inflammation
Official title: A Multicenter Study on the Application of LivQ-box® Parameters in the Diagnosis of Liver Inflammation in Patients with Non-alcoholic Fatty Liver Disease
Run by Wuxi Hisky Medical Technology Co Ltd · NCT06802731 · Data updated 2026-11-12
This study is testing if the LivQ-box® can help doctors better diagnose liver inflammation in people with nonalcoholic fatty liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 365 (estimated) |
| Sponsor | Wuxi Hisky Medical Technology Co Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | March 31, 2025 |
| Study ends | June 30, 2025 |
| Registry record updated | January 31, 2025 |
| Trial ID | NCT06802731 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old diagnosed with NAFLD and without other liver diseases.
✕Probably not a fit
Patients with liver diseases such as viral hepatitis, autoimmune liver disease, or those with a history of excessive alcohol consumption may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the correlation between LivQ-box® parameters, measured by iLivTouch, and the severity of liver inflammation in patients diagnosed with nonalcoholic fatty liver disease (NAFLD). It involves a multi-center approach, analyzing data from 240 NAFLD patients, both retrospectively and prospectively. The study collects laboratory results, iLivTouch measurements, and liver biopsy findings to determine the diagnostic value of these parameters and establish cut-off values for different stages of liver inflammation.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic accuracy for liver inflammation in NAFLD patients, leading to better management and treatment strategies.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in using non-invasive methods for diagnosing liver conditions, suggesting potential for success.
Who can join: the full rules
Show full inclusion / 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);
Where it's running
-
Beijing Tsinghua Changgung Hospital (BTCH) affiliated to Tsinghua University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Lai Wei
- Email: weilai@pkuph.edu.cn
- Phone: +86 13601281862
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.