NCT03861663

Venue Ultrasound Evaluation - Israel

Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Israel

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ultrasound Exam in Emergency/Medical Care

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-01-29
• Completion: 2018-01-29
• First posted: 2019-03-04
• Last updated: 2019-03-04

Locations

1 site across 1 country: Israel