Loading clinical trials...
Loading clinical trials...
Real-World Evaluation of the Performance of Eko's Heart Murmur Detection Algorithm When Used by Front-line Healthcare Providers on Geriatric Patients
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Parker Jewish Institute of Health Care and Rehabilitation
New Hyde Park, New York, United States
Start Date
June 1, 2021
Primary Completion Date
December 31, 2021
Completion Date
December 31, 2021
Last Updated
December 9, 2022
68
ACTUAL participants
Use of Eko DUO electronic stethoscope
DEVICE
Lead Sponsor
Eko Devices, Inc.
NCT07191730
NCT07484009
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions