Status:
COMPLETED
Venue Ultrasound Evaluation - Israel
Lead Sponsor:
GE Healthcare
Collaborating Sponsors:
Rambam Health Care Campus
Conditions:
Ultrasound Exam in Emergency/Medical Care
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2018
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03861663
Start Date
December 1 2017
End Date
January 29 2018
Last Update
March 4 2019
Active Locations (1)
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1
Rambam Health Care Center
Haifa, Israel, 3109601