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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03653572
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Information provided by (Responsible Party):
GE Healthcare

Brief 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.

Condition or disease Intervention/treatment Phase
Ultrasound Use in Emergency/Medical Care Device: Ultrasound exam Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Canada
Actual Study Start Date : June 14, 2017
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Eligible Subjects
All subjects will be enrolled into a single arm and will undergo an ultrasound exam, per the protocol.
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.

Primary Outcome Measures :
  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 from device users.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03653572

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Canada, Quebec
Hopital Notre-Dame
Montréal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
GE Healthcare
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Principal Investigator: Martin Girard, MD Hopital Notre-Dame

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Responsible Party: GE Healthcare Identifier: NCT03653572    
Other Study ID Numbers: 110.04-2016-GES-0007
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by GE Healthcare:
Emergency care
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes