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NCT03778411 · ClinicalTrials.gov registry record
Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Assessment of Spleen Stiffness Using VCTE by FibroScan.
A clinical trial of Advanced Chronic Liver Disease, NASH, sponsored by Indiana University.
- Completed
- Registry status
- 298
- Enrollment target
- 1
- Study location
NCT03778411 is a study of Advanced Chronic Liver Disease, NASH that has completed, run by Indiana University. The registered enrollment target is 298 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03778411, a study of Advanced Chronic Liver Disease, NASH, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- 298 participants
- Enrollment target
- 1
- Study location
Study 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 Touch by measuring SS (splenic stiffness) Specific Aims: SS by VCTE will be measured in this single center clinical study comprising of 200 patients with cACLD (defined by LSM ≥10 kilopascals (kPa) according to the Baveno VI recommendations) who have not had a liver transplant and 100 subjects who are post-liver transplant. The association between baseline SS values will be examined in relation to the manifestations of portal hypertension such as esophageal or gastric varices. Specific Aim: To examine the relationship between SS and the presence of esophageal and gastric varices in patients with compensated advanced chronic liver disease (cACLD). Proposed Study Design: This is a cross sectional study that evaluates the relationship between SS by VCTE in patients with cACLD and manifestations of portal hypertension.
Conditions Studied
Interventions
- DEVICE VCTE with splenic stiffness measurement
Study Locations (1)
Indiana
- Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2023-03-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03778411
The ClinicalTrials.gov registry entry for NCT03778411 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 298 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Advanced Chronic Liver Disease, NASH appearing as the primary indexed condition, and to 1 intervention - of which VCTE with splenic stiffness measurement is the first listed.
NCT03778411 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT03778411 about?
NCT03778411 is a clinical study titled "Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Assessment of Spleen Stiffness Using VCTE by FibroScan.". 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 Touch by measuring SS (splenic stiffness) Specific Aims: SS by VCTE will be measured in this single ce...
What is the current status of trial NCT03778411?
This trial is currently completed. The enrollment target is 298 participants. The study started on 2020-12-01. Estimated completion is 2023-03-03.
What conditions does trial NCT03778411 study?
This clinical trial studies the following conditions: Advanced Chronic Liver Disease, NASH.
What interventions are being tested in trial NCT03778411?
The interventions under investigation include: VCTE with splenic stiffness measurement (DEVICE).
Who is sponsoring clinical trial NCT03778411?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03778411 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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