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:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT06394206
Eligibility Criteria:
Inclusion Criteria:
* Patients seen in outpatient gastroenterology clinics with hepatic steatosis.
* Diagnosed with hepatic steatosis through ultrasound or abdominal CT scan
* Mild to moderate fibrosis as assessed by elastography or FibroScan (F1-F3) or with a Fibrosis-4 (FIB-4) Index less than 3.5.
* Signature of informed consent for study inclusion, either by the participant themselves or by their legal representative.
Exclusion Criteria:
* Patients who do not have any hepatic imaging test conducted in the last 5 years.
* Conditions other than hepatic steatosis requiring gastroenterological follow-up.
* Abusive alcohol consumption, defined as weekly intake of \> 50 g in women and more than 70 g in men.
* Cognitive or affective disorders limiting the ability to cooperate with study procedures.
* Participation in another clinical trial involving experimental intervention during the period of this trial and/or establishing visit schedules incompatible with this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06394206
Study Brief:
Protocol Section:
NCT06394206