Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04933890 |
| Other study ID # |
2021.5 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
December 2022 |
| Source |
Eko Devices, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to evaluate how Eko AI performs in the real world, front-line
setting where the availability of sophisticated, expensive diagnostic tools is limited, and
where there is a premium on detecting VHD early in its course.
Description:
Echocardiography is the state of the art for diagnosing VHD. However, without an effective
pre-screening tool, many echocardiograms ("echos") are being ordered unnecessarily. A recent
study found that greater than 66% of all echos performed in the United States do not alter
clinical management, while an additional 4% may be deemed inappropriate altogether.
Because of this, echos now make up a disproportionately large segment of healthcare
expenditure. Each year, 1 in 5 Medicare enrollees receives an echo at a total cost of $1.2
billion, or 11% of total Medicare spending on imaging services. This is compounded by the
fact that an estimated 35 million Americans live in medically underserved areas, where
patients must travel an average of 56 miles to see a specialist and receive an echo. This
does not encourage compliance, and only adds to cost, lost working hours, and inconvenience.
There is therefore a growing, unmet need for better VHD screening tools. Tools that will
consistently, reliably, quickly, and cheaply identify VHD when it is early and asymptomatic,
when patients can be managed early and appropriately, and when they are at the lowest risk
from an intervention. Such a tool will have a positive impact on the cost of care, patient
and provider experience, and healthcare outcomes.
The FDA-cleared Eko CORE and Eko DUO electronic stethoscopes offer clinicians a familiar and
inexpensive tool that is widely accepted by patients and providers, while at the same time
offer sensors and artificial intelligence technology that can improve screening and detection
of medical conditions such as VHD. Both the CORE and the DUO feature sound amplification
during auscultation - the CORE also offers active noise cancellation - which improves the
ability of the clinician to detect nuanced changes in heart sounds.
