Evaluating LivQ-box® for diagnosing liver inflammation
A Multicenter Study on the Application of LivQ-box® Parameters in the Diagnosis of Liver Inflammation in Patients with Non-alcoholic Fatty Liver Disease
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 |
|---|---|
| Enrollment | 365 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wuxi Hisky Medical Technology Co Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06802731 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with NAFLD and without other liver diseases.
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.
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 performed: While this approach is innovative, similar studies have shown promise in using non-invasive methods for diagnosing liver conditions, suggesting potential for success.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.