Data Collection for Next Generation Ultrasound Technology Development

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.

Official Title
-----------------
Data Collection for Next Generation Ultrasound Technology Development

Conditions
-----------------
Endstage Renal Disease

Intervention / Treatment
-----------------
* Device: Ultrasound scan


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MHD Population Ultrasound<br>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. | Device: Ultrasound scan<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Diagnostic Ultrasound Exams | Collection (number) of ultrasound images representative of sonographic findings routinely observed in the general imaging population. | 1 day |