Data Collection for Next Generation Ultrasound Technology Development

General Electric (GE)

Status: Completed

Conditions: Endstage Renal Disease

Treatments: Device: Ultrasound scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02946229

110.04-2016-GES-0005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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142 participants in 1 patient group

MHD Population Ultrasound

Other group

Description:

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.

Treatment:

Device: Ultrasound scan