Ultrasound Exam in Emergency/Medical Care
Conditions
Brief summary
The study purpose is to collect images and user feedback from the Next Generation Venue Ultrasound system, components, and accessories under clinical conditions, as required for device development and optimization.
Detailed description
Adult patients (aged \>18 years) will be enrolled that present for emergency or immediate medical care, in facilities such as the intensive care unit (ICU), US unit, and/or other departments. Subjects may or may not have a clinical indication for ultrasound scanning as part of their regular medical care and will be required to meet the inclusion criteria and none of the exclusion criteria. If a subject has a clinical indication for ultrasound exam, the routine exam will be performed with the standard equipment, and an additional exam will be performed using the investigational ultrasound device.
Interventions
DEVICEUltrasound
Eligible subjects will be positioned for their ultrasound exam, which will take a similar amount of time and be performed in a similar manner as standard of care ultrasound exams at the site. The type and duration of ultrasound exam will be based on the subject's clinical condition.
Sponsors
Rambam Health Care Campus
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Device evaluation - feasibility
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults (aged 18 years of age or older) at the time of consent; 2. Eligible to undergo ultrasound scanning per the site standard of care (with or without a clinical indication for scanning); 3. Able and willing to provide written informed consent for participation
Exclusion criteria
1. Are pregnant subjects 2. Require procedures that cannot be readily completed using available investigational devices; 3. Require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obtain Image sets using Ultrasound Venue System | Two months | Number of representative image sets for subjects enrolled in study |
| Periodic user feedback | Two months | Periodic user feedback data (Clinician User Preference Survey) from device users on device performance for quality optimization. The feedback will not be aggregated or statistically analyzed. The scale is a 1-5 Likert score (1 - Poor, 2 - Needs Improvement, 3 - As expected/Equal, 4 - Better then expected, 5 - Excellent) There is no total score. |
Countries
Israel
Outcome results
None listed