NCT03653572

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to collect images data sets from clinical cases and periodic user feedback on the Next Generation Venue ultrasound system under clinical conditions. This is a medical device study designed as a clinical, open label, unblinded, non-randomized, prospective, feasibility research study.

Detailed description

Adult patients (aged \>18 years) will be enrolled as they present for emergency or immediate medical care, in facilities such as the intensive care unit (ICU), cardiac care unit (CCU), 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. Eligible subjects will undergo an ultrasound exam using the investigational ultrasound device. The exam type will be based on the subject's clinical condition. Users performing the scans will periodically be asked to provide feedback on User Survey forms prepared by the Sponsor. Image data sets from investigational exam will be stored electronically and de-identified data will be disclosed to the Sponsor.Results are for use in development and optimization of a next generation ultrasound system being developed by study Sponsor, GE Healthcare (GEHC) prior to future commercial release.

Conditions

• Ultrasound Use in Emergency/Medical Care

Interventions

Type	Name	Description
DEVICE	Ultrasound exam	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: 2017-06-14
• Primary completion: 2017-08-01
• Completion: 2017-08-02
• First posted: 2018-08-31
• Last updated: 2018-08-31

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study