Status:
UNKNOWN
Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US
Lead Sponsor:
New Discovery LLC
Collaborating Sponsors:
NYU Langone Health
Stanford University
Conditions:
Liver Fibrosis
Fatty Liver
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
Clinical phase: Phase IV investigator-initiated study Study centers planned: Approximately 4 centers in different regions of the USA Objectives: 1. Primary Objectives To evaluate the consistency of ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 24 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT06051669
Start Date
September 24 2023
End Date
March 1 2025
Last Update
October 13 2023
Active Locations (4)
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1
Stanford University
Redwood City, California, United States, 94305
2
Rush University
Chicago, Illinois, United States, 60612
3
NYU Langone
New York, New York, United States, 11355
4
Baylor University
Houston, Texas, United States, 76798