CClinicalTrials.gg
CompletedNCT02946229Updated Nov 2, 2018Results posted

Data Collection for Next Generation Ultrasound Technology Development

An interventional study of Ultrasound scan in Endstage Renal Disease, sponsored by GE Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-02.

Sponsored by GE Healthcare · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Endstage Renal Disease
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 142 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

GE Healthcare is the lead sponsor of 168 studies on the registry; 19 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
142 participants (actual)

Study arms

  • 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

Interventions

  • DeviceUltrasound 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.

06

What researchers measure

Primary outcomes

  1. Number of Diagnostic Ultrasound Exams

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

    Time frame: 1 day

07

Results

Posted Nov 2, 2018

Participant flow

Participant flow — Overall Study
MilestoneMHD Population Ultrasound
Started142
Completed142
Not completed0

Outcome measures

PrimaryNumber of Diagnostic Ultrasound Exams

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

Time frame:
1 day
Reported as:
Count of participants · Participants
Number of Diagnostic Ultrasound Exams
ParticipantsMHD Population Ultrasound
Number of Diagnostic Ultrasound Exams142

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MHD Population Ultrasound0/142 (0%)0/142 (0%)0/142 (0%)

Baseline characteristics

All enrolled subjects

Age, Customized
Age, Customized(Participants)MHD Population Ultrasound
>=18 years142
Sex/Gender, Customized
Sex/Gender, Customized(Participants)MHD Population Ultrasound
Male or Female142
08

Study locations

1 site
  • Research By Design
    Evergreen Park, Illinois 60805, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02946229
Lead sponsor
GE Healthcare
Responsible party
Sponsor
First posted
Oct 27, 2016
Start date
Oct 26, 2016
Primary completion
Dec 6, 2016
Completion
Dec 6, 2016
Results posted
Nov 2, 2018
Last update
Nov 2, 2018

Study contacts

Paul Crawford, MD
principal investigator · Research By Design, LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion