Comparing two devices for assessing liver health in adults

Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US: A Multicenter, Cross-sectional, and Prospective Study

This study is testing two different devices to see which one does a better job of measuring liver health in adults.

Quick facts

• Study type: Observational
• Enrollment: 418 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: New Discovery LLC (Industry-sponsored)
• Locations: 4 sites (Redwood City, California and 3 other locations)
• Trial ID: NCT06051669 on ClinicalTrials.gov

What this trial studies

This observational study aims to compare the effectiveness of two devices, iLivTouch and FibroScan, in measuring liver stiffness and fat content in adult patients across multiple centers in the USA. The study will evaluate the consistency of liver stiffness measurements and operational features of both devices, while also assessing the correlation of these measurements with established liver health scores. Approximately four centers will participate, and the study will include a diverse patient population with indications for liver examination.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with indications for liver examination and recent relevant test results.

Not a fit: Patients with a history of excessive alcohol consumption, severe liver disease, or other serious systemic conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy and reliability of liver health assessments, leading to better management of liver conditions.

How similar studies have performed: Previous studies have shown success in using similar non-invasive devices for liver assessment, indicating potential for this approach.

Eligibility criteria

Inclusion Criteria:

* a. Adults aged above 18 years old who have at least one indication for TE examination determined by the physicians;
* b. Patients who have test results for platelet count, ALT, AST, globulin, HBA1c, and total bilirubin (TBIL) levels within 60 days;
* c. Patients who are willing to participate in the clinical study and can sign ICF.

Exclusion Criteria:

* a. Excessive drinking history within 90 days: For women-140 grams of alcohol per week or more; For men-210 grams of alcohol per week or more;
* b. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase AST \>100 U/ml (or 2.5 × upper limit of normal (ULN) and/or total bilirubin (TBIL) \> 1.8 mg/d (or \>1.5 × ULN =1.2 mg/d);
* c. Patients with a history or current evidence of decompensated liver cirrhosis;
* d. Patients with various space-occupying tumors and cysts in the right liver;
* e. Patients with other serious systemically diseases or a history of malignant tumors;
* f. Patients with ascites;
* g. Patients with a non-healing wound on the right upper abdomen at this moment;
* h. Patients with intracavitary implantation of instruments;
* i. Pregnant women (urine pregnancy test should be performed for all women with child-bearing potential during screening);
* j. Any history of organ transplantation and existing functional grafts (except corneal or hair transplantation);
* k. Lack of or limited legal capacity.

Where this trial is running

Redwood City, California and 3 other locations

• Stanford University — Redwood City, California, United States (Not_yet_recruiting)
• Rush University — Chicago, Illinois, United States (Not_yet_recruiting)
• NYU Langone — New York, New York, United States (Recruiting)
• Baylor University — Houston, Texas, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Calvin Q Pan, Dr

Conditions Liver Fibrosis; Fatty Liver