Venue Ultrasound Evaluation – Israel

Overview

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.

Full Title of Study: “Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories – Israel”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 29, 2018

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Other: Eligible Subjects
    • All subjects will be enrolled into a single arm and will undergo an ultrasound exam, per the protocol.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GE Healthcare
  • Collaborator
    • Rambam Health Care Campus
  • Provider of Information About this Clinical Study
    • Sponsor

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