Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Israel
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GE Healthcare
- Enrollment
- 53
- Locations
- 2
- Primary Endpoint
- Obtain Image sets using Ultrasound Venue System
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (aged 18 years of age or older) at the time of consent;
- •Eligible to undergo ultrasound scanning per the site standard of care (with or without a clinical indication for scanning);
- •Able and willing to provide written informed consent for participation
Exclusion Criteria
- •Are pregnant subjects
- •Require procedures that cannot be readily completed using available investigational devices;
- •Require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.
Arms & Interventions
Eligible Subjects
All subjects will be enrolled into a single arm and will undergo an ultrasound exam, per the protocol.
Intervention: Ultrasound (Device)
Outcomes
Primary Outcomes
Obtain Image sets using Ultrasound Venue System
Time Frame: Two months
Number of representative image sets for subjects enrolled in study
Periodic user feedback
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported