Last updated on May 2015

Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for Diagnosis of Hepatic Steatosis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Liver Steatosis | Fatty Liver | Hepatic Steatosis
  • Age: Between 18 - 65 Years
  • Gender: Male or Female
  • Other:
    Subject at the age of 18 to 65 years, non-limited gender.
    Within two weeks of FibroTouch examination, qualified histological specimens of liver
    biopsy are required. Using the liver biopsy needle of 16G or 14CT, puncture and
    remove more than 2.0 centimeters long liver tissue (including at least 11 portal
    areas, no less than 6 complete portal areas and the minimum length of specimen should
    be more than 1.0 centimeter).
    Willing and able to abide by all principles and complete all study procedures.
    Willing and can provide written informed consent form by patient or patient's legal

You may not be eligible for this study if the following are true:

  • Subject with active or suspected cancer or history of malignant tumor by evidence
    within 5 years before enrolling. And the subject who has the liver malignant tumors
    injury cannot participate in this study.
    There is evidence that the subject has a history of alcohol overdoses* or drug abuse.
    Definition of alcohol overdoses: 40 gram (g)/day for male and 40 g/day for female.
    Alcohol intake (g) = the volume of drinking (ml) × alcohol percentage (%, v/v) × 0.8
    (g/ml); 1g alcohol is the equal of 25-40 ml of beer, 8-10ml of Chinese rice wine,
    5-12ml of (grape) wine, 3-7ml of health care liquor or Chinese spirits.
    Subject with alcoholic liver disease and hepatitis C.
    Pregnant or nursing woman, and subject with a pregnant plan and is unwilling to take
    contraceptive measures during this study.
    Subject with history of organ transplantation or has functional grafts (except for
    the cornea or hair graft).
    Subject with non-healing wound on the right upper abdomen at this moment.
    In the investigator's opinion, the subject is unsuitable to participate in the study
    as he or she has a history of serious illness, or other evidence shown that the
    ubject has any other serious illness.
    Subject who participates in other clinical trial at the same time.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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