Cardiac DiseaseNCT03897140
Point-of-Care Echocardiography With Assistance Technology
A study testing Diagnostic Test: Limited Echocardiogram in people with Cardiac Disease, run by Sara Guttas at 2 sites in United States.
Trial summary
Establish the effectiveness of the Bay Labs, Inc. EchoGPS software in enabling RNs to acquire echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Diagnostic Test: Limited Echocardiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Mar 2019to 23 May 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients must meet the following inclusion criteria to participate in the study:
- Patients scheduled for an echocardiographic examination
- Patients ≥18 years old
Who cannot join
- Patients must NOT meet any of the following exclusion criteria to participate in the trial:
- Unable to lie flat for study
- Patients experiencing a known or suspected acute cardiac event
- Patients with severe chest wall abnormalities
- Patients who have undergone pneumonectomy
- Patients unwilling or unable to give written informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Medicine, Bluhm Cardiovascular Institute
Chicago, Illinois, 60611
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
About this study
Official title: Study for Point-of-Care Echocardiography With Assistance Technology
Establish the effectiveness of the Bay Labs, Inc. EchoGPS software in enabling RNs to acquire echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).
Read the detailed description
To validate clinical use of Bay Labs, Inc. EchoGPS guidance software by registered nurses (RNs) with no prior scanning experience to acquire limited two-dimensional echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).
- Conditions
- Cardiac Disease
- Being tested
- Diagnostic Test: Limited Echocardiogram
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: Limited EchocardiogramDiagnostic test
STUDY SOFTWARE non-significant risk (NSR) Bay Labs EchoGPS software interfaced with the Terason uSmart 3200t FDA 510(k)-cleared, commercially available ultrasound EchoGPS software communicates with the ultrasound image formation engine of the 510(k)-cleared Terason uSmart 3200t through an application programming interface (API). EchoGPS will be used to provide visual guidance feedback to users during image acquisition. For this study, RNs will use EchoGPS to perform limited echocardiogram examinations.
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for an echocardiogram | Experimental | Patients ≥18 years scheduled for an echocardiographic examination. This is a non-randomized, un-blinded, study in patients with an indication for an echocardiographic examination. Enrolled patients will be stratified into two groups based on known cardiac abnormalities to ensure a sufficient number of patients with cardiac abnormalities and into 3 strata of BMI: normal, overweight and obese. Receives: Diagnostic Test: Diagnostic Test: Limited Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study-level Assessment
The primary endpoints for the study are separate patient-level assessments of whether the patient study is of adequate image quality to make a qualitative visual assessment for a particular clinical parameter (ie., Yes/No). Expert cardiologist readers will independently provide assessments and they will be blinded to the assessments from the other readers as well as whether the images were acquired by an RN or sonographer.
The Outcome Measure will be reported as the percentage of patient studies for which the panel of cardiologist readers adjudicated as being of sufficient image quality to make a particular clinical assessment.
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Secondary outcomes (8)
View-level Assessment
The Outcome Measure will be reported as the percentage of patient studies with diagnostic quality clip for a particular Standard View acquired in the study. Expert cardiologist readers will independently provide assessments and they will be blinded to the assessments from the other readers as well as whether the images were acquired by an RN or sonographer.
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Inter-User Variability (Primary Clinical Parameters)
- Comparison of user variability for primary clinical parameters (measured as the coefficient variation for binary assessment of whether the study is of diagnostic quality to make a particular clinical assessment)
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Inter-User Variability (Acquisition Time)
- View level acquisition time (minutes and seconds)
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Patient-Level Acquisition time
- Patient level acquisition time (minutes and seconds)
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
View-Level Acquisition time
- View-level acquisition time (minutes and seconds)
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Comparison of study exam and control exam (View-Level Results)
- Comparison of View level results measured as percent agreement of images with diagnostic quality
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Comparison of study exam and control exam (Patient-Level Results)
- Comparison of patient level results measured as percent agreement of patient exams of sufficient quality to make a particular clinical assessment
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Comparison of study exam and control exam (Task-Based Assessment)
- Comparison of qualitative assessments from study and control exam to assess whether cardiologists reach a similar decision with study exam images and control exam images
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start25 Mar 2019
- Primary completion23 May 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Guttas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Sara Guttas, Caption Health, Inc.
- Investigators
- Akhil Narang, MD, Principal investigator, Northwestern Medicine, Bluhm Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897140
- Sponsor's protocol ID
- EchoGPSPivotal1.0
- Status last verified
- Sep 2019
- First submitted
- 23 Mar 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data (IPD) will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Point-of-Care Echocardiography With Assistance Technology
- ClinicalTrials.gov ID
- NCT03897140
- Acronym / sponsor ID
- EchoGPSPivotal1.0
- Conditions
- Cardiac Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Sara GuttasIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 1 Apr 2019 (actual)
- 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.
Establish the effectiveness of the Bay Labs, Inc. EchoGPS software in enabling RNs to acquire echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).
Detailed description
To validate clinical use of Bay Labs, Inc. EchoGPS guidance software by registered nurses (RNs) with no prior scanning experience to acquire limited two-dimensional echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for an echocardiogram | Experimental | Diagnostic Test: Diagnostic Test: Limited EchocardiogramPatients ≥18 years scheduled for an echocardiographic examination. This is a non-randomized, un-blinded, study in patients with an indication for an echocardiographic examination. Enrolled patients will be stratified into two groups based on known cardiac abnormalities to ensure a sufficient number of patients with cardiac abnormalities and into 3 strata of BMI: normal, overweight and obese. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for an echocardiographic examination
- Patients ≥18 years old
Key exclusion criteria (6 listed)
- Patients must NOT meet any of the following exclusion criteria to participate in the trial:
- Unable to lie flat for study
- Patients experiencing a known or suspected acute cardiac event
- Patients with severe chest wall abnormalities
- Patients who have undergone pneumonectomy
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 |
|---|---|---|
| Diagnostic Test: Limited EchocardiogramSTUDY SOFTWARE non-significant risk (NSR) Bay Labs EchoGPS software interfaced with the Terason uSmart 3200t FDA 510(k)-cleared, commercially available ultrasound EchoGPS software communicates with the ultrasound image formation engine of the 510(k)-cleared Terason uSmart 3200t through an application programming interface (API). EchoGPS will be used to provide visual guidance feedback to users during image acquisition. For this study, RNs will use EchoGPS to perform limited echocardiogram examinations. | Diagnostic test | Patients scheduled for an echocardiogram |
Primary outcome
Study-level Assessment
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
The primary endpoints for the study are separate patient-level assessments of whether the patient study is of adequate image quality to make a qualitative visual assessment for a particular clinical parameter (ie., Yes/No). Expert cardiologist readers will independently provide assessments and they will be blinded to the assessments from the other readers as well as whether the images were acquired by an RN or sonographer. The Outcome Measure will be reported as the percentage of patient studies for which the panel of cardiologist readers adjudicated as being of sufficient image quality to make a particular clinical assessment.
8 secondary outcomes
View-level Assessment
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Inter-User Variability (Primary Clinical Parameters)
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Inter-User Variability (Acquisition Time)
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Patient-Level Acquisition time
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
View-Level Acquisition time
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Comparison of study exam and control exam (View-Level Results)
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Comparison of study exam and control exam (Patient-Level Results)
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Comparison of study exam and control exam (Task-Based Assessment)
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
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 17 Sep 2019.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will not be made available to other researchers.
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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.
Akhil Narang, MD principal investigator
Northwestern Medicine, Bluhm Cardiovascular Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Test: Limited Echocardiogram in people with Cardiac Disease, run by Sara Guttas at 2 sites 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 3 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 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Study-level Assessment (time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments). 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 17 Sep 2019.