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Stage 3 Fontan Operation Liver Ultrasound Study

NCT02269709 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-01-12

Study results available
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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.

Conditions

  • Fontan Operation

Interventions

DEVICE

ARFI Ultrasound

This research scan uses acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a new ultrasound technology in which unique sound waves create the images/pictures of the liver beng examined/scanned. This ultrasound scan will take approximately 10 minutes to complete.

Sponsors & Collaborators

Principal Investigators

  • Frank W DiPaola, MD · University of Michigan

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02269709 on ClinicalTrials.gov