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Completed

NCT Number: NCT03861663

Venue Ultrasound Evaluation - Israel

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.

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Key information

Conditions

Ultrasound Exam in Emergency/Medical Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Center

Haifa, 3109601, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ultrasound

Device

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.

Primary outcomes

  1. Obtain Image sets using Ultrasound Venue System

    Time frame: Two months

    Number of representative image sets for subjects enrolled in study

  2. 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.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • Rambam Health Care Campus

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2019
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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