Clinical Benefits of B-Flow Ultrasound

Not Applicable

Completed

• Conditions: Evidence of Liver Transplantation; Hypertension; Pregnancy, High Risk; Pregnancy; Arterial Occlusive Diseases

• Registration Number: NCT02008097
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-11
• Primary Completion: 2015-08-31
• Study Completion: 2015-09-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-28
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlating blood flow findings using B-flow imaging with standard clinical ultrasound.	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

Name	Time	Method
Correlating blood flow findings on B-flow imaging in pregnant women with pathology findings in the placenta.	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.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States