Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT02456766
Eligibility Criteria:
Inclusion Criteria:
* 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 guardian.
Exclusion Criteria:
* 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 subject has any other serious illness.
* Subject who participates in other clinical trial at the same time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02456766
Study Brief:
Protocol Section:
NCT02456766