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Data Collection for Next Generation Ultrasound Technology Development

Primary Purpose

Endstage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound scan
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Endstage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research By Design

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MHD Population Ultrasound

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 25, 2016
Last Updated
March 1, 2018
Sponsor
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02946229
Brief Title
Data Collection for Next Generation Ultrasound Technology Development
Official Title
Data Collection for Next Generation Ultrasound Technology Development
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 26, 2016 (Actual)
Primary Completion Date
December 6, 2016 (Actual)
Study Completion Date
December 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endstage Renal Disease

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MHD Population Ultrasound
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ultrasound scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Diagnostic Ultrasound Exams
Description
Collection (number) of ultrasound images representative of sonographic findings routinely observed in the general imaging population.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Crawford, MD
Organizational Affiliation
Research By Design, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research By Design
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Data Collection for Next Generation Ultrasound Technology Development

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