Data Collection for Next Generation Ultrasound Technology Development
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GE Healthcare
- Enrollment
- 142
- Locations
- 2
- Primary Endpoint
- Number of Diagnostic Ultrasound Exams
Study Overview
Brief Summary
The study is designed to collect data from a ultrasound device being used to evaluate feasibility of next generation algorithms for ultrasound data processing and does not test any health outcome.
Detailed Description
The study is designed to collect data from a ultrasound device being used to evaluate feasibility of next generation algorithms for ultrasound data processing and does not test any health outcome. All eligible adults (aged 18 or older) will contribute case data from a convenience sample of maintenance hemodialysis population available at the study site and consistent with feasibility assessment of the technology. A relatively large feasibility population is used due to the need to test feasibility of multiple features across variations within this population.
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
- •Are adults (aged 18 years of age or older) at the time of consent;
- •Are undergoing maintenance hemodialysis (MHD); AND
- •Are able and willing to provide written informed consent for participation
Exclusion Criteria
- •Have anatomical characteristics or comorbid medical conditions that prevent completion of ultrasound scanning using the study device; OR
- •Are potentially put at additional risk by participating, in the opinion of the investigator.
Arms & Interventions
MHD Population Ultrasound
Eligible subjects in a convenience population at the site (Maintenance Hemodialysis, MHD) incidentally undergoingnon-invasive cardiac, pulmonary, and abdominal ultrasound scanning on the commercially available GE Vivid S70 system for use in testing feasibility of new algorithms for processing this data.
Intervention: Ultrasound scan (Device)
Outcomes
Primary Outcomes
Number of Diagnostic Ultrasound Exams
Time Frame: 1 day
Collection (number) of ultrasound images representative of sonographic findings routinely observed in the general imaging population.
Secondary Outcomes
No secondary outcomes reported