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OpenTrials
Completed

NCT Number: NCT02008097

Clinical Benefits of B-Flow Ultrasound

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GE LOGIQ E9 Ultrasound System

Device

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.

Primary outcomes

  1. Correlating blood flow findings using B-flow imaging with standard clinical ultrasound.

    Time frame: 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.

    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.

Secondary outcomes

  1. Correlating blood flow findings on B-flow imaging in pregnant women with pathology findings in the placenta.

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • General Electric

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 11, 2013
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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