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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT05817994
Eligibility Criteria:
Inclusion Criteria:
* Adult (per local age threshold)
* Suspected liver disease based on abnormal liver function tests, standard ultrasound, transient elastography (Fibro Scan) or CT or MRI of the liver
* Planned upper endoscopy to evaluate for varices
* Planned liver biopsy based on suspected hepatitis or cirrhosis
Exclusion Criteria:
* Severe Coagulation/bleeding disorder as defined by INR \> 2 IU which cannot be corrected with FFP or Platelets \< 50,000 per microliter which cannot be corrected with platelet transfusion.
* Severe organ failure considered unsafe to undergo sedation (ASA class 4 or 5)
* Inability to provide informed consent
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT05817994
Study Brief:
Protocol Section:
NCT05817994