Endstage Renal Disease
Conditions
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.
Interventions
DEVICEUltrasound scan
Collection of ultrasound data sets that include routine ultrasound data (eg, extravascular lung fluid, cardiac velocity time integral and inferior vena cava) on the commercial GE Vivid S70 Ultrasound System which are used to test feasibility of next generation ultrasound algorithms being developed to process these data types.
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Are adults (aged 18 years of age or older) at the time of consent; 2. Are undergoing maintenance hemodialysis (MHD); AND 3. Are able and willing to provide written informed consent for participation
Exclusion criteria
1. Have anatomical characteristics or comorbid medical conditions that prevent completion of ultrasound scanning using the study device; OR 2. Are potentially put at additional risk by participating, in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Diagnostic Ultrasound Exams | 1 day | Collection (number) of ultrasound images representative of sonographic findings routinely observed in the general imaging population. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Ultrasound scan: Collection of ultrasound data sets that include routine ultrasound data (eg, extravascular lung fluid, cardiac velocity time integral and inferior vena cava) on the commercial GE Vivid S70 Ultrasound System which are used to test feasibility of next generation ultrasound algorithms being developed to process these data types. | 142 |
| Total | 142 |
Baseline characteristics
| Characteristic | MHD Population Ultrasound |
|---|---|
| Age, Customized >=18 years | 142 Participants |
| Sex/Gender, Customized Male or Female | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 142 |
| other Total, other adverse events | 0 / 142 |
| serious Total, serious adverse events | 0 / 142 |
Outcome results
Primary
Number of Diagnostic Ultrasound Exams
Collection (number) of ultrasound images representative of sonographic findings routinely observed in the general imaging population.
Time frame: 1 day
Population: No performance or efficacy data were studied; No statistical analysis was performed per the protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MHD Population Ultrasound | Number of Diagnostic Ultrasound Exams | 142 Participants |