Clinical Benefits of B-Flow Ultrasound (NCT02008097) | Clinical Trial Compass
CompletedNot Applicable
Clinical Benefits of B-Flow Ultrasound
United States180 participantsStarted 2013-10
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.