Clinical Benefits of B-Flow Ultrasound

April 28, 2018 updated by: Manjiri Dighe, University of Washington

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Liver transplant without a stent
Liver Transplant patients without a stent who are referred for liver ultrasound will have will have a B-Flow ultrasound exam using the GE LOGIQ E9 Ultrasound System .
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.
EXPERIMENTAL: Liver transplant with a stent
Liver transplant patients who are referred for angioplasty and stenting, or who have had angioplasty and stenting and are referred for liver ultrasound will have a B-Flow ultrasound exam using the GE LOGIQ E9 Ultrasound System.
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.
EXPERIMENTAL: Renal artery disease without a stent
Patients with hypertension or impaired renal function who are referred for renal ultrasound will have a B-Flow ultrasound exam using the GE LOGIQ E9 Ultrasound System.
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.
EXPERIMENTAL: Renal artery disease with a stent
Patients who are referred for angioplasty and stenting, or who have had angioplasty and stenting and are referred for renal ultrasound will have a B-Flow ultrasound exam using the GE LOGIQ E9 Ultrasound System.
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.
EXPERIMENTAL: Pregnancy, Normal
Pregnant women referred for an obstetrical ultrasound to evaluate a normal pregnancy; for example, to determine gestation or gestational age will have a B-Flow ultrasound exam using the GE LOGIQ E9 Ultrasound System.
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.
EXPERIMENTAL: Pregnancy, High Risk
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 will have a B-Flow ultrasound exam using the GE LOGIQ E9 Ultrasound System. Examples of risk factors include placenta previa, vaginal bleeding, suspected multiple gestation, suspected uterine abnormality, suspected fetal growth abnormality, advanced maternal age, a prior C-section, prior low birth weight baby, and prior preterm birth.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

General Electric

Investigators

  • Principal Investigator: Manjiri Dighe, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2013

Primary Completion (ACTUAL)

August 31, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 28, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45374

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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