Clinical Benefits of B-Flow Ultrasound

NCT02008097 | Completed

• 1 other identifier: 45374
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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. 1.Liver transplant patients: Improved real-time visualization of liver vessels is needed to improve diagnosis and assessment following stenting or angioplasty.
2. 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. 3.Pregnancy: We are proposing to use B-flow ultrasound as a way to evaluate placenta perfusion and assay for potential ischemia.

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (6)

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 .

Device: GE LOGIQ E9 Ultrasound System

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.

Device: GE LOGIQ E9 Ultrasound System

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.

Device: GE LOGIQ E9 Ultrasound System

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.

Device: GE LOGIQ E9 Ultrasound System

Pregnancy, Normal

EXPERIMENTAL

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

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.

Device: GE LOGIQ E9 Ultrasound System

Interventions

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.

Liver transplant with a stent; Liver transplant without a stent; Pregnancy, High Risk; Pregnancy, Normal; Renal artery disease with a stent; Renal artery disease without a stent

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• General Electric: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Manjiri Dighe, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: December 11, 2013
• Study Start: October 1, 2013
• Primary Completion: August 31, 2015
• Study Completion: September 1, 2015
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

US (1)