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:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT04389593
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects of any gender and any ethnic group with known or suspected NASH
* Subject is willing and able to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, and research MRI exam), and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images and clinical or research biopsy results
* Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents
* Subject has had or is expected to have a clinical or research biopsy within 150 days of the MR exam
Exclusion Criteria:
* VA subject
* \< 18 years of age
* Subject does not have a physician and does not wish to be contacted about possible incidental findings
* MRI contraindication(s)
* Subject knows that she is pregnant or states she is trying to become pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04389593
Study Brief:
Protocol Section:
NCT04389593