Data Collection for Next Generation Ultrasound Technology Development

NCT ID: NCT02946229

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-26
• Study Completion Date: 2016-12-06

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.

Conditions

Endstage Renal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Ultrasound scan

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Crawford, MD

Role: PRINCIPAL_INVESTIGATOR

Research By Design, LLC

Locations

Research By Design

Evergreen Park, Illinois, United States

Countries

United States

Other Identifiers

110.04-2016-GES-0005

Identifier Type: -

Identifier Source: org_study_id