Ultrasound Exam in Emergency/Medical CareNCT03861663
Venue Ultrasound Evaluation - Israel
A study testing Ultrasound in people with Ultrasound Exam in Emergency/Medical Care, run by GE Healthcare at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound Exam in Emergency/Medical Care
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2017to 29 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - 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.
Read the 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.
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Eligible Subjects | Other | All subjects will be enrolled into a single arm and will undergo an ultrasound exam, per the protocol. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain Image sets using Ultrasound Venue System
Number of representative image sets for subjects enrolled in study
Measured: Two months
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.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start1 Dec 2017
- Primary completion29 Jan 2018
- Study completion29 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Exam in Emergency/Medical CareStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Device evaluation - feasibility
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861663
- Sponsor's protocol ID
- 110.04-2016-GES-0008
- Status last verified
- Dec 2018
- First submitted
- 1 Mar 2018
- Last updated
- 4 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Israel
- ClinicalTrials.gov ID
- NCT03861663
- Acronym / sponsor ID
- 110.04-2016-GES-0008
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Device evaluation - feasibility
| Arm | Type | Receives |
|---|---|---|
| Eligible Subjects | Other | Device: UltrasoundAll subjects will be enrolled into a single arm and will undergo an ultrasound exam, per the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundEligible 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. | Device | Eligible Subjects |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Ultrasound Exam in Emergency/Medical Care
Not yet recruitingObservational study
Evaluation of an Online Application for Point of Care Ultrasound Training in General Internal Medicine Residents
Point of Care Ultrasound (POCUS), Ultrasound Exam in Emergency/Medical Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Ultrasound Exam in Emergency/Medical Care, run by GE Healthcare at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtain Image sets using Ultrasound Venue System (time frame: Two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019; AzTrials last refreshed its copy on 29 Oct 2026.