Data Collection for Next Generation Ultrasound Technology Development

NCT02946229 | Completed Results

• 1 other identifier: 110.04-2016-GES-0005
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Endstage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Number of Diagnostic Ultrasound Exams

  Collection (number) of ultrasound images representative of sonographic findings routinely observed in the general imaging population.

  1 day

Study Arms (1)

MHD Population Ultrasound

OTHER

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

Interventions

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.

MHD Population Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Research By Design

Evergreen Park, Illinois, 60805, United States

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Sean Lucas - Research Manager
• Organization: GE Healthcare

sean.lucas@ge.com

1-248-533-5575

Study Officials

• Paul Crawford, MD

  Research By Design, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: October 25, 2016
• First Posted: October 27, 2016
• Study Start: October 26, 2016
• Primary Completion: December 6, 2016
• Study Completion: December 6, 2016
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)