Status:
COMPLETED
Kosmos Trio and Ejection Fraction Pivotal Study
Lead Sponsor:
EchoNous Inc.
Collaborating Sponsors:
University of California, San Francisco
Revival Research Institute LLC
Conditions:
Cardiac Disease
Eligibility:
All Genders
18-89 years
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 4 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 16 2024
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT06027164
Start Date
August 4 2023
End Date
May 16 2024
Last Update
May 21 2024
Active Locations (1)
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1
Revival Research Institute LLC
Dearborn, Michigan, United States, 48126