Venue Ultrasound Evaluation - Israel

Ultrasound Exam in Emergency/Medical Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861663
• Other study ID #: 110.04-2016-GES-0008
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: January 29, 2018

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 29, 2018
• Est. primary completion date: January 29, 2018
• 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);

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;

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 Exam in Emergency/Medical Care

Intervention

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.

Locations

Country	Name	City	State
Israel	Rambam Health Care Center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

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 (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.	Two months