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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02269709
Other study ID # HUM00090329
Secondary ID
Status Completed
Phase N/A
First received October 15, 2014
Last updated December 13, 2017
Start date November 2014
Est. completion date July 2016

Study information

Verified date November 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Michigan Hospital Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Shear Wave Speed (Liver Stiffness) 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. 0-6 months
Secondary IVC Pressure Blood pressure in the IVC, the interior vena cava, was measured from a central line placed for patient care. Baseline and Follow Up Number 1 (approximately 24 -72 hours later)
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT01413308 - Pulmonary Functions Test in Patients After Fontan Operation N/A
Recruiting NCT02414321 - The Role of the Pulmonary Vasculature in the Fontan Circulation
Not yet recruiting NCT05474664 - Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation Phase 2