Data Collection for Next Generation Ultrasound Technology Development

March 1, 2018 updated by: GE Healthcare
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evergreen Park, Illinois, United States, 60805
        • Research By Design

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GE Healthcare

Investigators

  • Principal Investigator: Paul Crawford, MD, Research by Design, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2016

Primary Completion (Actual)

December 6, 2016

Study Completion (Actual)

December 6, 2016

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 27, 2016

Study Record Updates

Last Update Posted (Actual)

November 2, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110.04-2016-GES-0005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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