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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT04003766
Eligibility Criteria:
Inclusion Criteria:
1. All patients referred for liver biopsy for any reason
2. Informed consent obtained from the patient
3. ≥ 18 years old
4. Able to undergo conscious sedation for EUS procedure
Exclusion Criteria:
1. \<18 years old
2. Unable to obtain informed consent from the patient
3. Medically unfit for sedation
4. Pregnant patients
5. Presence of a mass lesion in the liver requiring biopsy visualized on cross-sectional imaging
6. Irreversible coagulopathy as determined by platelet count \< 50,000 mm3 or International Normalized Ratio (INR) \> 1.5
7. Unable to stop anticoagulation or anti-platelet therapy for 5 days prior to the procedure
8. Hemophilia
9. Presence of an alternative etiology for elevated liver tests seen during liver biopsy, e.g. choledocholithiasis discovered during EUS examination
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04003766
Study Brief:
Protocol Section:
NCT04003766