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

Description

This is a multi-center, cross-sectional, and prospective study that will recruit patients from multiple hospitals or outpatient clinics in the USA to the comparison of iLivTouch and FibroScan for the assessment of liver fibrosis and steatosis in adult patients.

Conditions

Liver Fibrosis, Fatty Liver

Study Overview

Study Details

Study overview

This is a multi-center, cross-sectional, and prospective study that will recruit patients from multiple hospitals or outpatient clinics in the USA to the comparison of iLivTouch and FibroScan for the assessment of liver fibrosis and steatosis in adult patients.

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

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

Condition
Liver Fibrosis
Intervention / Treatment

-

Contacts and Locations

Redwood City

Stanford University, Redwood City, California, United States, 94305

Chicago

Rush University, Chicago, Illinois, United States, 60612

New York

NYU Langone, New York, New York, United States, 11355

Houston

Baylor University, Houston, Texas, United States, 76798

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

New Discovery LLC,

Calvin Q. Pan, STUDY_CHAIR, New York University Langone Health

Study Record Dates

2025-03