Back to resultsVenue Ultrasound Evaluation - Israel
Primary Purpose
Ultrasound Exam in Emergency/Medical Care
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional device feasibility trial for Ultrasound Exam in Emergency/Medical Care
Eligibility Criteria
Inclusion Criteria:
- Adults (aged 18 years of age or older) at the time of consent;
- Eligible to undergo ultrasound scanning per the site standard of care (with or without a clinical indication for scanning);
- Able and willing to provide written informed consent for participation
Exclusion Criteria:
- Are pregnant subjects
- Require procedures that cannot be readily completed using available investigational devices;
- Require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.
Sites / Locations
- Rambam Health Care Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Eligible Subjects
Arm Description
All subjects will be enrolled into a single arm and will undergo an ultrasound exam, per the protocol.
Outcomes
Primary Outcome Measures
Obtain Image sets using Ultrasound Venue System
Number of representative image sets for subjects enrolled in study
Periodic user feedback
Periodic user feedback data (Clinician User Preference Survey) from device users on device performance for quality optimization. The feedback will not be aggregated or statistically analyzed. The scale is a 1-5 Likert score (1 - Poor, 2 - Needs Improvement, 3 - As expected/Equal, 4 - Better then expected, 5 - Excellent) There is no total score.
Secondary Outcome Measures
Full Information
NCT ID
NCT03861663
First Posted
March 1, 2018
Last Updated
March 1, 2019
Sponsor
GE Healthcare
Collaborators
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT03861663
Brief Title
Venue Ultrasound Evaluation - Israel
Official Title
Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Israel
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
January 29, 2018 (Actual)
Study Completion Date
January 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
Collaborators
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The study purpose is to collect images and user feedback from the Next Generation Venue Ultrasound system, components, and accessories under clinical conditions, as required for device development and optimization.
Detailed Description
Adult patients (aged >18 years) will be enrolled that present for emergency or immediate medical care, in facilities such as the intensive care unit (ICU), US unit, and/or other departments. Subjects may or may not have a clinical indication for ultrasound scanning as part of their regular medical care and will be required to meet the inclusion criteria and none of the exclusion criteria. If a subject has a clinical indication for ultrasound exam, the routine exam will be performed with the standard equipment, and an additional exam will be performed using the investigational ultrasound device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultrasound Exam in Emergency/Medical Care
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Device evaluation - feasibility
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eligible Subjects
Arm Type
Other
Arm Description
All subjects will be enrolled into a single arm and will undergo an ultrasound exam, per the protocol.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Eligible subjects will be positioned for their ultrasound exam, which will take a similar amount of time and be performed in a similar manner as standard of care ultrasound exams at the site. The type and duration of ultrasound exam will be based on the subject's clinical condition.
Primary Outcome Measure Information:
Title
Obtain Image sets using Ultrasound Venue System
Description
Number of representative image sets for subjects enrolled in study
Time Frame
Two months
Title
Periodic user feedback
Description
Periodic user feedback data (Clinician User Preference Survey) from device users on device performance for quality optimization. The feedback will not be aggregated or statistically analyzed. The scale is a 1-5 Likert score (1 - Poor, 2 - Needs Improvement, 3 - As expected/Equal, 4 - Better then expected, 5 - Excellent) There is no total score.
Time Frame
Two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (aged 18 years of age or older) at the time of consent;
Eligible to undergo ultrasound scanning per the site standard of care (with or without a clinical indication for scanning);
Able and willing to provide written informed consent for participation
Exclusion Criteria:
Are pregnant subjects
Require procedures that cannot be readily completed using available investigational devices;
Require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.
Facility Information:
Facility Name
Rambam Health Care Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Venue Ultrasound Evaluation - Israel
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