Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US
Status unconfirmed
Conditions studied: Liver Fibrosis, Fatty Liver
In brief
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.
Key facts
- Study ID
- NCT06051669
- Run by
- New Discovery LLC
- People needed
- 418
- Starts
- 2023-09-24
- Expected to finish
- 2025-03-01
- Last updated by the study team
- 2023-10-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- NYU Langone — New York, New York, United States (enrolling)
- Stanford University — Redwood City, California, United States
- Rush University — Chicago, Illinois, United States
- Baylor University — Houston, Texas, United States
Full record on ClinicalTrials.gov
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