Cardiac DiseaseNCT06027164
Kosmos Trio and Ejection Fraction Pivotal Study
An observational study of Cardiac Disease, run by EchoNous Inc. at 1 site in United States.
Trial summary
This is a single-group, observational study which will involve obtaining two echo scans of recruited patients. All recruited patients will undergo echo scans by both novice users (nurses) and experts (echo sonographers). Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Portable Ultrasound System
- Type of treatment
- Medical device
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2023to 16 May 2024
- Phase
- Observational
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients admitted to the Emergency Department Observation Unit (EDOU) will be eligible for enrollment. Patients admitted to the EDOU often spend a prolonged amount of time in the EDOU (often > 24 hours) awaiting further testing, therapies, or specialist consultations, thus recruiting from this pool of patients is most likely to allow for completion of study procedures without impacting the course of their clinical care
Who may be able to join
- Aged 18-89 years of age
- Have capacity to provide written consent either themselves or via healthcare proxy as determined by subjects' clinical care teams
- Have an anticipated timeline in the EDOU long enough to allow for completion of study procedures without causing delay to subjects' usual clinical care
Who cannot join
- Heart rate > 110 beats per minute at the time of recruitment
- Pregnant women
- Prior chest surgery
- Chest wall deformities or injuries (i.e. wounds, infections, etc)
- Limited mobility precluding them from turning in bed independently
- Speak a primary language other than English or Spanish
- Vulnerable populations including: patients being evaluated for psychiatric crises, incarcerated individuals
- Unwilling or unable to consent to study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Revival Research Institute LLC
Dearborn, Michigan, 48126
About this study
This is a single-group, observational study which will involve obtaining two echo scans of recruited patients. All recruited patients will undergo echo scans by both novice users (nurses) and experts (echo sonographers). Image quality between novices and experts as well as the ability to calculate LVEF from novice and expert scans and the quality of the LVEF calculated via KOSMOS-EF compared to LVEF calculations by expert cardiologists will occur in post-hoc Echo image analysis
- Conditions
- Cardiac Disease
- Being tested
- Portable Ultrasound System
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable Ultrasound SystemDevice
EchoNous KOSMOS
| Study group | Role | What they receive |
|---|---|---|
| Study Subjects | Ultrasound scans conducted by novice users and experts on this cohort. Receives: Device: Portable Ultrasound System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Global Left Ventricular Function
A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurses is of sufficient image quality to make a qualitative visual assessment of the Global Left Ventricular Function.
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Assessment of Left Ventricular Size
A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of the Left Ventricular Size.
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Assessment of Non-Trivial Pericardial Effusion
A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Non-Trivial Pericardial Effusion.
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Assessment of Right Ventricular Size
A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Right Ventricle Size.
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Secondary outcomes (3)
Assessment of Automatic Structure Labelling
A panel of cardiologists will access and determine via a majority vote if the frame-level false discovery rate (FDR) of automated cardiac structure labeling as determined by expert cardiologists for scans acquired by cardiac sonographers.
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Manual vs. KOSMOS-EF for Sonographer Scans
Measurements are computed for A4C and A2C scans acquired by sonographers . We will compare KOSMOS-EF LVEF calculation to LVEF calculated by a panel of cardiologists via a majority vote.
Measured: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Assessment of Left Atrial Size
A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Left Atrial Size.
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 posted7 Sep 2023
- Study start4 Aug 2023
- Primary completion31 Aug 2023
- Study completion16 May 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- EchoNous Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco, Revival Research Institute LLC, Centaur Labs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027164
- Sponsor's protocol ID
- ECHO-004
- Status last verified
- May 2024
- First submitted
- 27 Jul 2023
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kosmos Trio and Ejection Fraction Pivotal Study
- ClinicalTrials.gov ID
- NCT06027164
- Acronym / sponsor ID
- ECHO-004
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- EchoNous Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco, Revival Research Institute LLC, Centaur Labs
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 7 Sep 2023 (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.
This is a single-group, observational study which will involve obtaining two echo scans of recruited patients. All recruited patients will undergo echo scans by both novice users (nurses) and experts (echo sonographers). Image quality between novices and experts as well as the ability to calculate LVEF from novice and expert scans and the quality of the LVEF calculated via KOSMOS-EF compared to LVEF calculations by expert cardiologists will occur in post-hoc Echo image analysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Subjects | – | Device: Portable Ultrasound SystemUltrasound scans conducted by novice users and experts on this cohort. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the Emergency Department Observation Unit (EDOU) will be eligible for enrollment. Patients admitted to the EDOU often spend a prolonged amount of time in the EDOU (often > 24 hours) awaiting further testing, therapies, or specialist consultations, thus recruiting from this pool of patients is most likely to allow for completion of study procedures without impacting the course of their clinical care
Key inclusion criteria (3 listed)
- Aged 18-89 years of age
- Have capacity to provide written consent either themselves or via healthcare proxy as determined by subjects' clinical care teams
- Have an anticipated timeline in the EDOU long enough to allow for completion of study procedures without causing delay to subjects' usual clinical care
Key exclusion criteria (8 listed)
- Heart rate > 110 beats per minute at the time of recruitment
- Pregnant women
- Prior chest surgery
- Chest wall deformities or injuries (i.e. wounds, infections, etc)
- Limited mobility precluding them from turning in bed independently
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 |
|---|---|---|
| Portable Ultrasound SystemEchoNous KOSMOS | Device | Study Subjects |
Primary outcome
Assessment of Global Left Ventricular Function
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurses is of sufficient image quality to make a qualitative visual assessment of the Global Left Ventricular Function.
Assessment of Left Ventricular Size
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of the Left Ventricular Size.
Assessment of Non-Trivial Pericardial Effusion
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Non-Trivial Pericardial Effusion.
Assessment of Right Ventricular Size
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Right Ventricle Size.
3 secondary outcomes
Assessment of Automatic Structure Labelling
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Manual vs. KOSMOS-EF for Sonographer Scans
Time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Assessment of Left Atrial Size
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 21 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by EchoNous Inc. 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 3 inclusion and 8 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 21 May 2024. 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?
Assessment of Global Left Ventricular Function (time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments). The study lists 4 primary outcomes in all. 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 21 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.