Venue Ultrasound Evaluation - Israel

Not Applicable

Completed

• Conditions: Ultrasound Exam in Emergency/Medical Care
• Interventions: Device: Ultrasound

• Registration Number: NCT03861663
• Lead Sponsor: GE Healthcare

Brief 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.

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2018-01-29
• Study Completion: 2018-01-29
• Study First Submitted: 2018-03-01
• Status Verified: 2018-12
• Study First Submitted QC: 2019-03-01
• Last Update Submitted: 2019-03-01
• Study First Posted: 2019-03-04
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Rambam Health Care Center; 🇮🇱 Haifa, Israel