Clinical Benefits of B-Flow Ultrasound

Hypertension Clinical Trial

Official title:

Evaluation of Clinical Benefits of B-Flow With the LOGIQ E9 Ultrasound System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008097
• Other study ID #: 45374
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: September 1, 2015

Study information

• Verified date: April 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goals of this study are to evaluate the efficacy of the B-flow capability on the LOGIQ E9 system in three clinical focus areas.

1. Liver transplant patients: Improved real-time visualization of liver vessels is needed to improve diagnosis and assessment following stenting or angioplasty.

2. Renal artery disease: Improved real-time visualization of the renal arteries would enable a more rapid and accurate assessment of renal artery disease (stenosis, dissection, occlusion, aneurysm) and facilitate follow-up evaluations after renal artery interventions.

3. Pregnancy: We are proposing to use B-flow ultrasound as a way to evaluate placenta perfusion and assay for potential ischemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 1, 2015
• Est. primary completion date: August 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

Subjects must be referred for a standard clinical ultrasound exam.

• Patients who have had a Liver Transplant and are referred for a liver ultrasound or angioplasty & stent placement;

• Patients with hypertension, impaired renal function, or renal artery disease who are referred for a renal ultrasound or angioplasty & stent placement;

• Pregnant women referred for an obstetrical ultrasound to evaluate a normal pregnancy for example to determine gestation or gestational age;

• Pregnant women referred for an obstetrical ultrasound to evaluate a high risk pregnancy due to a medical condition present before or during pregnancy for either the mother or the baby.

Exclusion Criteria:

• Minors;

• Prisoners;

• Unable to understand the nature of the study or to consent;

• Very sick or experiencing significant pain;

• Undergoing an emergency ultrasound;

• Pregnant and undergoing an ultrasound to evaluate suspected congenital malformation, abruptio placenta or fetal death.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Evidence of Liver Transplantation
• Hypertension
• Pregnancy
• Pregnancy, High Risk

Intervention

Device:
• GE LOGIQ E9 Ultrasound System
Subjects will have an ultrasound exam using the GE LOGIQ E9 Ultrasound System which has computer software that combines the color-flow image and B-mode image to produce the new "B-Flow" method of ultrasound.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	General Electric

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlating blood flow findings using B-flow imaging with standard clinical ultrasound.	The new "B-Flow" method combines the color-flow image and the B-mode image to show the tissue and blood flow at the same time. This makes it easier to see the blood flow and smaller blood vessels in real time. Findings from the B-Flow method will be correlated with the standard clinical ultrasound to validate the efficacy of B-Flow for detection and classification of stenosis and other abnormalities in blood vessels.	Day 1. Participants will have B-flow US performed the same day as their clinical US and measures will be assessed at the time of the B-flow US.
Secondary	Correlating blood flow findings on B-flow imaging in pregnant women with pathology findings in the placenta.	Findings from the B-Flow method will be correlated with the standard clinical ultrasound to validate the efficacy of B-Flow for detection and classification of stenosis and other abnormalities in blood vessels. B-Flow findings will also be correlated with histopathologic diagnosis in the placenta after delivery.	Up to 6 months. Pregnant women who have B-flow US will be followed until delivery (up to 6 months from B-flow US) and pathology data on the placenta will be collected if a histopathology assessment is done.