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| Name | Class |
|---|---|
| General Electric | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver transplant without a stent | Experimental | 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 . |
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| Liver transplant with a stent | Experimental | 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. |
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| Renal artery disease without a stent | Experimental | 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. |
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| Renal artery disease with a stent | Experimental | 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. |
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| Pregnancy, Normal | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Subjects must be referred for a standard clinical ultrasound exam.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manjiri Dighe, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 29, 2018 | |
| Reset | Jul 27, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 29, 2018 | Jul 27, 2018 |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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| Pregnancy, High Risk | Experimental | 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. |
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| 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. |