Evidence of Liver TransplantationNCT02008097
Clinical Benefits of B-Flow Ultrasound
A study testing GE LOGIQ E9 Ultrasound System in people with Evidence of Liver Transplantation and Arterial Occlusive Diseases, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Evidence of Liver Transplantation, Arterial Occlusive Diseases, Hypertension
- What is being tested?
- GE LOGIQ E9 Ultrasound System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 1 Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Clinical Benefits of B-Flow With the LOGIQ E9 Ultrasound System
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.
- Liver transplant patients: Improved real-time visualization of liver vessels is needed to improve diagnosis and assessment following stenting or angioplasty.
- 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.
- 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
- Being tested
- GE LOGIQ E9 Ultrasound System
- Keywords
- Ultrasound, Ultrasonography, Liver transplantation, Arterial Occlusive Diseases, Hypertension, Pregnancy, High Risk, Pregnancy
- Medical subject headings
- Arterial Occlusive Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GE LOGIQ E9 Ultrasound SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: GE LOGIQ E9 Ultrasound System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startOct 2013
- Primary completion31 Aug 2015
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence of Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Principal investigator, Manjiri Dighe, University of Washington
- Investigators
- Manjiri Dighe, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008097
- Sponsor's protocol ID
- 45374
- Status last verified
- Apr 2018
- First submitted
- 24 Oct 2013
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Benefits of B-Flow With the LOGIQ E9 Ultrasound System
- ClinicalTrials.gov ID
- NCT02008097
- Acronym / sponsor ID
- 45374
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- Oct 2013 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Liver transplant patients: Improved real-time visualization of liver vessels is needed to improve diagnosis and assessment following stenting or angioplasty.
- 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.
- Pregnancy: We are proposing to use B-flow ultrasound as a way to evaluate placenta perfusion and assay for potential ischemia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Liver transplant without a stent | Experimental | Device: GE LOGIQ E9 Ultrasound SystemLiver 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 . |
| Liver transplant with a stent | Experimental | Device: GE LOGIQ E9 Ultrasound SystemLiver 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. |
| Renal artery disease without a stent | Experimental | Device: GE LOGIQ E9 Ultrasound SystemPatients 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. |
| Renal artery disease with a stent | Experimental | Device: GE LOGIQ E9 Ultrasound SystemPatients 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. |
| Pregnancy, Normal | Experimental | Device: GE LOGIQ E9 Ultrasound SystemPregnant 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. |
| Pregnancy, High Risk | Experimental | Device: GE LOGIQ E9 Ultrasound SystemPregnant 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Minors;
- Prisoners;
- Unable to understand the nature of the study or to consent;
- Very sick or experiencing significant pain;
- Undergoing an emergency ultrasound;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GE LOGIQ E9 Ultrasound SystemSubjects 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. | Device | 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 |
Primary outcome
Correlating blood flow findings using B-flow imaging with standard clinical ultrasound.
Time frame: 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.
1 secondary outcome
Correlating blood flow findings on B-flow imaging in pregnant women with pathology findings in the placenta.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manjiri Dighe, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GE LOGIQ E9 Ultrasound System in people with Evidence of Liver Transplantation and Arterial Occlusive Diseases, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlating blood flow findings using B-flow imaging with standard clinical ultrasound. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.