Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US

Launched by NEW DISCOVERY LLC · Sep 20, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two methods, iLivTouch and FibroScan, to assess liver health in adults, particularly looking at liver fibrosis (scarring) and steatosis (fatty liver). The study is taking place at multiple hospitals and outpatient clinics across the United States and is currently recruiting participants who are 18 years or older and have a reason for needing a liver examination. To join, you’ll need to have some recent blood test results and be willing to sign consent for participation.

To be eligible, you should not have had excessive alcohol intake recently or certain serious liver conditions. If you decide to take part in this study, you can expect to undergo tests using both iLivTouch and FibroScan to see how well these methods work for evaluating liver health. This research aims to improve how doctors assess liver conditions, which is important for better patient care.

Gender

ALL

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.