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NCT02269709 · ClinicalTrials.gov registry record · NA
Stage 3 Fontan Operation Liver Ultrasound Study
A NA study of Fontan Operation, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT02269709: Completed NA study of Fontan Operation, sponsored by University of Michigan.
NCT02269709 is a NA study of Fontan Operation that has completed, run by University of Michigan. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02269709, a NA study of Fontan Operation, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare the liver stiffness, which can be caused by congestion and fibrosis in pediatric patients before and after a Fontan heart operation. A new form of ultrasound elastography (Acoustic Radiation Force Impulse, or ARFI) will measure liver stiffness.
Primary Outcome
ARFI shear wave speed measurements were done on the right lobe of the liver. Measurement units are m/s (meters per second). A total of 8 measurements were performed on each subject at each time point.The 8 values were performed on each subject and averaged.
Conditions Studied
Interventions
- DEVICE ARFI Ultrasound
Study Locations (1)
Michigan
- University of Michigan Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-07 |
| Phase | NA |
What the finished NCT02269709 record still lists
NCT02269709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Fontan Operation appearing as the primary indexed condition, and to 1 intervention - of which ARFI Ultrasound is the first listed.
NCT02269709 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02269709 about?
NCT02269709 is a clinical study titled "Stage 3 Fontan Operation Liver Ultrasound Study". The purpose of this study is to compare the liver stiffness, which can be caused by congestion and fibrosis in pediatric patients before and after a Fontan heart operation. A new form of ultrasound elastography (Acoustic Radiation Force Impulse, or ARFI) will measure liver stiffness.
What is the current status of trial NCT02269709?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2014-11. Estimated completion is 2016-07.
What conditions does trial NCT02269709 study?
This clinical trial studies the following conditions: Fontan Operation.
What interventions are being tested in trial NCT02269709?
The interventions under investigation include: ARFI Ultrasound (DEVICE).
Who is sponsoring clinical trial NCT02269709?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02269709 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02269709's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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