Clinical trial NCT02008097: Clinical Benefits of B-Flow Ultrasound
Official title: Evaluation of Clinical Benefits of B-Flow With the LOGIQ E9 Ultrasound System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evidence of Liver Transplantation
Arterial Occlusive Diseases
Hypertension
Pregnancy, High Risk
Pregnancy
Keywords: Ultrasound
Ultrasonography
Liver transplantation
Arterial Occlusive Diseases
Hypertension
Pregnancy, High Risk
Pregnancy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2013-12-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: Correlating blood flow findings using B-flow imaging with standard clinical ultrasound.
timeFrame: 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 outcomes:
measure: Correlating blood flow findings on B-flow imaging in pregnant women with pathology findings in the placenta.
timeFrame: 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.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Manjiri Dighe, MD
role: PRINCIPAL_INVESTIGATOR
References: