Cardiac DiseaseEPISODENCT03642730
Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging
A study testing TransThoracic Echocardiography imaging in people with Cardiac Disease and Heart Failure, run by Philips Healthcare at 1 site in France.
Trial summary
This prospective study is a pilot study for evaluating a guidance system that aims to facilitate high-quality echocardiographic acquisitions. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease, Heart Failure, Cardiac Ischemia
- What is being tested?
- TransThoracic Echocardiography imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 1 Jan 2021
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All volunteers must have the ability to provide informed consent.
- All volunteers should be affiliated to the French Social Security.
- All volunteers will be scheduled for a routine transthoracic echocardiography exam in the echocardiography laboratory at the investigation site as part of standard care.
Who cannot join
- Subjects with congenital heart diseases (except bicuspid aortic valve)
- Pregnant women
- Adults lacking decisional capacity
- Adults placed under a legal protection regime (guardianship, curatorship, judicial protection)
- Adults not affiliated to the French Social Security
- Adults in emergent or critical condition
Show all 9Show fewer
- Adults with active pain in the intended scanning region
- Adults with active skin disease or lesions in the intended scanning region
- Adults with allergy/sensitivity to ultrasound gel
Trial locations and contacts
1 site in 1 country.
About this study
This prospective study is a pilot study for evaluating a guidance system that aims to facilitate high-quality echocardiographic acquisitions.
Read the detailed description
The primary objective of this study is to assess the feasibility for non-expert users (medical professionals but non-certified sonographers) to acquire parasternal, apical and subcostal views of suitable quality by using an existing ultrasound device (CE-marked, available in the market) and an additional guidance system (software prototype + probe motion tracking device). Such a system will help the user to place the probe on the patient and provide guidance for optimal acquisition of parasternal, apical and subcostal views.
The secondary objective of this study is to assess the feasibility for non-expert users to reproduce a simple clinical protocol by using an existing ultrasound device and the same additional guidance system.
- Conditions
- Cardiac Disease, Heart Failure, Cardiac Ischemia
- Being tested
- TransThoracic Echocardiography imaging
- Keywords
- echocardiography, training, follow-up
- Medical subject headings
- Heart Diseases, Heart Failure, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransThoracic Echocardiography imagingDevice
ultrasound scanning
| Study group | Role | What they receive |
|---|---|---|
| Scanned patients | Experimental | Scanned patients TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors Receives: Device: TransThoracic Echocardiography imaging |
| Non-expert scanning volunteers | Experimental | Non-expert scanning volunteers (among the medical staff at the clinical site) TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors Receives: Device: TransThoracic Echocardiography imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiography acquisition score [in %] [Operator's outcome]
Composite measurement that characterizes the echocardiography acquisition of the operator who is being assessed with respect to a 2D reference acquisition The echocardiography acquisition score is a combination of the view type score and the image quality score
Measured: Day 1
Time to acquisition [in seconds] [Operator's performance]
Time to acquisition [in seconds] to reach an echocardiography acquisition score of 25%, 50%, 75% and 90%
Measured: Day 1
Displacement [in mm] of the echocardiography probe with respect to the 2D reference acquisition [Technical reproducibility]
Displacement [in mm] of the echocardiography probe at the acquisition time with respect to the 2D reference acquisition [Reproducibility of the probe position and orientation]
Measured: Day 1
Displacement [in mm] of the echocardiography probe with respect to the ideal acquisition [Geometrical reliability]
Displacement [in mm] of the echocardiography probe at the acquisition time with respect to the ideal (geometrical) acquisition estimated from 3D reference acquisition [Geometrical reliability of the probe position and orientation]
Measured: Day 1
Secondary outcomes (1)
Left ventricular Ejection Fraction [in %] [Measurement reproducibility]
Left ventricular Ejection Fraction [in %] by Simpson's biplane method
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Dec 2017
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Saloux, MD, Principal investigator, Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642730
- Sponsor's protocol ID
- ICBE-2-11984
- Acronym
- EPISODE
- Status last verified
- Feb 2021
- First submitted
- 9 May 2018
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- 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 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging
- ClinicalTrials.gov ID
- NCT03642730
- Acronym / sponsor ID
- EPISODE / ICBE-2-11984
- Conditions
- Cardiac Disease, Heart Failure, Cardiac Ischemia
- Keywords
- echocardiography, training, follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 22 Aug 2018 (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.
This prospective study is a pilot study for evaluating a guidance system that aims to facilitate high-quality echocardiographic acquisitions.
Detailed description
The primary objective of this study is to assess the feasibility for non-expert users (medical professionals but non-certified sonographers) to acquire parasternal, apical and subcostal views of suitable quality by using an existing ultrasound device (CE-marked, available in the market) and an additional guidance system (software prototype + probe motion tracking device). Such a system will help the user to place the probe on the patient and provide guidance for optimal acquisition of parasternal, apical and subcostal views.
The secondary objective of this study is to assess the feasibility for non-expert users to reproduce a simple clinical protocol by using an existing ultrasound device and the same additional guidance system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scanned patients | Experimental | Device: TransThoracic Echocardiography imagingScanned patients TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors |
| Non-expert scanning volunteers | Experimental | Device: TransThoracic Echocardiography imagingNon-expert scanning volunteers (among the medical staff at the clinical site) TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All volunteers must have the ability to provide informed consent.
- All volunteers should be affiliated to the French Social Security.
- All volunteers will be scheduled for a routine transthoracic echocardiography exam in the echocardiography laboratory at the investigation site as part of standard care.
Key exclusion criteria (9 listed)
- Subjects with congenital heart diseases (except bicuspid aortic valve)
- Pregnant women
- Adults lacking decisional capacity
- Adults placed under a legal protection regime (guardianship, curatorship, judicial protection)
- Adults not affiliated to the French Social Security
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 |
|---|---|---|
| TransThoracic Echocardiography imagingultrasound scanning | Device | Non-expert scanning volunteers, Scanned patients |
Primary outcome
Echocardiography acquisition score [in %] [Operator's outcome]
Time frame: Day 1
Composite measurement that characterizes the echocardiography acquisition of the operator who is being assessed with respect to a 2D reference acquisition The echocardiography acquisition score is a combination of the view type score and the image quality score
Time to acquisition [in seconds] [Operator's performance]
Time frame: Day 1
Time to acquisition [in seconds] to reach an echocardiography acquisition score of 25%, 50%, 75% and 90%
Displacement [in mm] of the echocardiography probe with respect to the 2D reference acquisition [Technical reproducibility]
Time frame: Day 1
Displacement [in mm] of the echocardiography probe at the acquisition time with respect to the 2D reference acquisition [Reproducibility of the probe position and orientation]
Displacement [in mm] of the echocardiography probe with respect to the ideal acquisition [Geometrical reliability]
Time frame: Day 1
Displacement [in mm] of the echocardiography probe at the acquisition time with respect to the ideal (geometrical) acquisition estimated from 3D reference acquisition [Geometrical reliability of the probe position and orientation]
1 secondary outcome
Left ventricular Ejection Fraction [in %] [Measurement reproducibility]
Time frame: Day 1
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 3 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Cardiac Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Eric Saloux, MD principal investigator
Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TransThoracic Echocardiography imaging in people with Cardiac Disease and Heart Failure, run by Philips Healthcare at 1 site in France.
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 9 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 3 Feb 2021. 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 France. 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?
Echocardiography acquisition score [in %] [Operator's outcome] (time frame: Day 1). The study lists 4 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 3 Feb 2021.