Ventricular DysfunctionNCT03887286
Focused Cardiac Ultrasound
A study testing Philips EPIQ 7 ultrasound machine and Philips Lumify Broadband sector array transducer in people with Ventricular Dysfunction and Pericardial Effusion, run by University of Miami at 1 site in United States.
Trial summary
To compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventricular Dysfunction, Pericardial Effusion, Valvular Disease
- What is being tested?
- Philips EPIQ 7 ultrasound machine and Philips Lumify Broadband sector array transducer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 30 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients presenting to pediatric cardiology clinic at Holtz Children's hospital requiring comprehensive or limited transthoracic echocardiogram.
- Willing and able to provide informed consent or assent.
- In clinically stable condition as assessed by the principal investigator..
- With adequate echocardiographic windows.
Who cannot join
- Patients with poor echocardiographic windows.
- Patients who refuse informed consent.
- Pregnant women.
- Prisoners.
- Patients deemed unfit to participate in the clinical trial as assessed by the principal investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Accuracy of Focused Cardiac Ultrasound Using an FDA Approved Hand-held Ultrasound Device in Outpatient Setting in Our Institution.
To compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device.
- Being tested
- Philips EPIQ 7 ultrasound machine, Philips Lumify Broadband sector array transducer
- Medical subject headings
- Ventricular Dysfunction, Pericardial Effusion, Heart Septal Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips EPIQ 7 ultrasound machineDevice
Standard transthoracic echocardiography
Philips Lumify Broadband sector array transducerDevice
Portable hand-held ultrasound device
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | All participants to receive standard transthoracic echocardiogram and hand held echocardiogram Receives: Device: Philips EPIQ 7 ultrasound machine; Device: Philips Lumify Broadband sector array transducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies.
Comparison of diagnostic ability of portable hand-held cardiac ultrasound with standard transthoracic echocardiography
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 Apr 2019
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Sokoloski, University of Miami
- Investigators
- Mary Sokoloski, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887286
- Sponsor's protocol ID
- 20181089
- Status last verified
- May 2020
- First submitted
- 21 Mar 2019
- Last updated
- 16 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Accuracy of Focused Cardiac Ultrasound Using an FDA Approved Hand-held Ultrasound Device in Outpatient Setting in Our Institution.
- ClinicalTrials.gov ID
- NCT03887286
- Acronym / sponsor ID
- 20181089
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Posted 16 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: Philips EPIQ 7 ultrasound machine, Device: Philips Lumify Broadband sector array transducerAll participants to receive standard transthoracic echocardiogram and hand held echocardiogram |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients presenting to pediatric cardiology clinic at Holtz Children's hospital requiring comprehensive or limited transthoracic echocardiogram.
- Willing and able to provide informed consent or assent.
- In clinically stable condition as assessed by the principal investigator..
- With adequate echocardiographic windows.
Key exclusion criteria (5 listed)
- Patients with poor echocardiographic windows.
- Patients who refuse informed consent.
- Pregnant women.
- Prisoners.
- Patients deemed unfit to participate in the clinical trial as assessed by the principal investigator.
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 |
|---|---|---|
| Philips EPIQ 7 ultrasound machineStandard transthoracic echocardiography | Device | treatment group |
| Philips Lumify Broadband sector array transducerPortable hand-held ultrasound device | Device | treatment group |
Primary outcome
Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies.
Time frame: Day 1
Comparison of diagnostic ability of portable hand-held cardiac ultrasound with standard transthoracic echocardiography
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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The JenaValve ALIGN-AR LVAD Registry
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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.
Mary Sokoloski, M.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Philips EPIQ 7 ultrasound machine and Philips Lumify Broadband sector array transducer in people with Ventricular Dysfunction and Pericardial Effusion, run by University of Miami 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 4 inclusion and 5 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 16 Jun 2020. 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?
Yes. Results are posted in the registry (first posted 16 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. (time frame: Day 1). 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 16 Jun 2020.