Kosmos Trio and Ejection Fraction Pivotal Study

NCT06027164 | Completed FDA Device

• 1 other identifier: ECHO-004
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  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

  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

  Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments

Study Arms (1)

Study Subjects

Ultrasound scans conducted by novice users and experts on this cohort.

Device: Portable Ultrasound System

Interventions

Portable Ultrasound System DEVICE

EchoNous KOSMOS

Study Subjects

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EchoNous Inc.: lead
• University of California, San Francisco: collaborator
• Revival Research Institute LLC: collaborator
• Centaur Labs: collaborator

Study Sites (1)

Revival Research Institute LLC

Dearborn, Michigan, 48126, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: September 7, 2023
• Study Start: August 4, 2023
• Primary Completion: August 31, 2023
• Study Completion: May 16, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

US (1)