Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2013-10-31
2015-09-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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 .
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
100 Years
ALL
No
Sponsors
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General Electric
INDUSTRY
University of Washington
OTHER
Responsible Party
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Manjiri Dighe
Associate Professor of Radiology
Principal Investigators
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Manjiri Dighe, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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45374
Identifier Type: -
Identifier Source: org_study_id
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