Status:
COMPLETED
Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Assessment of Spleen Stiffness Using VCTE by FibroScan.
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Echosens
Conditions:
Advanced Chronic Liver Disease, NASH
Eligibility:
All Genders
18+ years
Brief Summary
Hypothesis: The severity of portal hypertension in compensated advanced chronic liver disease (cACLD) can be assessed using vibration controlled transient elastography (VCTE) via the FibroScan® 502 To...
Detailed Description
A new term, compensated advanced chronic liver disease (cACLD) defining patients in the early phases of severe chronic liver disease, including both patients with severe fibrosis or pre-cirrhotic pati...
Eligibility Criteria
Inclusion
- Adults aged 18 years or older
- Ability to provide informed consent
- Previous Fibroscan with LSM ≥10 kilopascals (kPa)
Exclusion
- Inability or refusal to provide informed consent
- Fasting for less than three hours prior to the scan
- Subject is a pregnant or lactating female
- Subject with current, significant alcohol consumption
- Subject is unable to reliably quantify alcohol consumption based upon local study physician judgment
- Patients with a pacemaker or defibrillator
- Acute hepatitis defined as AST/ALT \> 500 U/L
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 3 2023
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT03778411
Start Date
December 1 2020
End Date
March 3 2023
Last Update
April 19 2024
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202