Data Collection for Next Generation Ultrasound Technology Development

Endstage Renal Disease Clinical Trial

Official title:

Data Collection for Next Generation Ultrasound Technology Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946229
• Other study ID #: 110.04-2016-GES-0005
• Status: Completed
• Phase: N/A
• Start date: October 26, 2016
• Est. completion date: December 6, 2016

Study information

• Verified date: March 2018
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 6, 2016
• Est. primary completion date: December 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endstage Renal Disease
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Research By Design	Evergreen Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Diagnostic Ultrasound Exams	Collection (number) of ultrasound images representative of sonographic findings routinely observed in the general imaging population.	1 day