An interventional study of Ultrasound in Ultrasound Exam in Emergency/Medical Care, sponsored by GE Healthcare. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-04.
Sponsored by GE Healthcare · Not applicable, Interventional, and Device feasibility
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.
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.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's enrollment of 53 is below the median of 145 across 931 interventional studies indexed under Emergencies.
Browse Emergencies studies →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.
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Exclusion Criteria:
All subjects will be enrolled into a single arm and will undergo an ultrasound exam, per the protocol.
Device: Ultrasound
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.
Obtain Image sets using Ultrasound Venue System
Number of representative image sets for subjects enrolled in study
Time frame: Two months
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.
Time frame: Two months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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GE Healthcare