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Clinical Benefits of B-Flow Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02008097
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Manjiri Dighe, University of Washington

Brief 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.

Condition or disease Intervention/treatment Phase
Evidence of Liver Transplantation Arterial Occlusive Diseases Hypertension Pregnancy, High Risk Pregnancy Device: GE LOGIQ E9 Ultrasound System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Clinical Benefits of B-Flow With the LOGIQ E9 Ultrasound System
Actual Study Start Date : October 2013
Actual Primary Completion Date : August 31, 2015
Actual Study Completion Date : September 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008097


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
General Electric
Investigators
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Principal Investigator: Manjiri Dighe, MD University of Washington
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Responsible Party: Manjiri Dighe, Associate Professor of Radiology, University of Washington
ClinicalTrials.gov Identifier: NCT02008097    
Other Study ID Numbers: 45374
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Keywords provided by Manjiri Dighe, University of Washington:
Ultrasound
Ultrasonography
Liver transplantation
Arterial Occlusive Diseases
Hypertension
Pregnancy, High Risk
Pregnancy
Additional relevant MeSH terms:
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Hypertension
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases