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OpenTrials
Completed

NCT Number: NCT02946229

Data Collection for Next Generation Ultrasound Technology Development

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.

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Key information

Conditions

Endstage Renal Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research By Design

Evergreen Park, Illinois, 60805, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound scan

Device

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2016
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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