Data Collection for Next Generation Ultrasound Technology Development

Not Applicable

Completed

• Conditions: Endstage Renal Disease
• Interventions: Device: Ultrasound scan

• Registration Number: NCT02946229
• Lead Sponsor: GE Healthcare

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.

Study Timeline

• Study First Submitted: 2016-10-25
• Study Start: 2016-10-26
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-27
• Primary Completion: 2016-12-06
• Study Completion: 2016-12-06
• Results First Submitted: 2017-08-15
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-01
• Last Update Submitted: 2018-03-01
• Results First Posted: 2018-11-02
• Last Update Posted: 2018-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MHD Population Ultrasound	Ultrasound scan	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.

Primary Outcome Measures

Name	Time	Method
Number of Diagnostic Ultrasound Exams	1 day	Collection (number) of ultrasound images representative of sonographic findings routinely observed in the general imaging population.

Trial Locations

Locations (1)

Research By Design; 🇺🇸 Evergreen Park, Illinois, United States