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

Not Applicable

Completed

• Conditions: Ultrasound Use in Emergency/Medical Care
• Interventions: Device: Ultrasound exam

• Registration Number: NCT03653572
• Lead Sponsor: GE Healthcare

Brief 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.

Study Timeline

• Study Start: 2017-06-14
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-02
• Study First Submitted: 2018-01-22
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-28
• Last Update Submitted: 2018-08-28
• Study First Posted: 2018-08-31
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Adults (aged 18 years of age or older) at the time of consent;
2. Eligible to undergo ultrasound scanning per the site standard of care (with or without a clinical indication for scanning); AND
3. Able and willing to provide written informed consent for participation.

Exclusion Criteria

1. Are pregnant subjects;
2. Require procedures that cannot be readily completed using available investigational devices; OR
3. Require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eligible Subjects	Ultrasound exam	All subjects will be enrolled into a single arm and will undergo an ultrasound exam, per the protocol.

Primary Outcome Measures

Name	Time	Method
Periodic user feedback	Two months	Periodic user feedback data from device users.
Obtain Image sets using Ultrasound Venue System	Two months	Number of representative image sets for subjects enrolled in study

Trial Locations

Locations (1)

Hopital Notre-Dame; 🇨🇦 Montréal, Quebec, Canada