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

Ultrasound Use in Emergency/Medical Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653572
• Other study ID #: 110.04-2016-GES-0007
• Status: Completed
• Phase: N/A
• Start date: June 14, 2017
• Est. completion date: August 2, 2017

Study information

• Verified date: August 2018
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Ultrasound Use in Emergency/Medical Care

Intervention

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.

Locations

Country	Name	City	State
Canada	Hopital Notre-Dame	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obtain Image sets using Ultrasound Venue System	Number of representative image sets for subjects enrolled in study	Two months
Primary	Periodic user feedback	Periodic user feedback data from device users.	Two months