Cardiac Output MeasurementsNCT05734664
An Exploratory Clinical Study Non-invasive Monitoring of Cardiac Outputs
A study testing Pulsify sensor and State-of-the-art ultrasound equipment in people with Cardiac Output Measurements and Healthy Subjects, run by Pulsify Medical at 1 site in Belgium.
Trial summary
Pulsify Medical aims at developing a sensor designed for the non-invasive, continuous and real-time monitoring of cardiac hemodynamics in patients at risk based on new transducer technology and artificial intelligence. It relies on real-time 3D greyscale ultrasound reconstruction of the LV myocardium. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Output Measurements, Healthy Subjects
- What is being tested?
- Pulsify sensor and State-of-the-art ultrasound equipment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Oct 2022to 23 Jan 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers can participate in this study if they:
- are aged over 18 years old
- have no known cardiovascular diseases
- are willing and able to comply with all investigation related procedures
Who cannot join
- Volunteers with arrhythmias, PM or ICD
- Volunteers with life supporting electronic devices (e.g. pacemakers)
- Volunteers with bad echocardiographic windows
- Volunteers post recent thorax surgery and open chest wounds
- Volunteers with abnormal thorax configuration (COPD, scoliosis, pectus excavatum, etc.) on criteria for the selection of topics
- Women in gestation
- Women that are breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Clinical Study for the Development of a Novel Ultrasound Transducer Technology Intended for Non-invasive Monitoring of Cardiac Outputs
Pulsify Medical aims at developing a sensor designed for the non-invasive, continuous and real-time monitoring of cardiac hemodynamics in patients at risk based on new transducer technology and artificial intelligence. It relies on real-time 3D greyscale ultrasound reconstruction of the LV myocardium. This medical device is still under development and the main objective of this clinical investigation is to gather data on the accuracy of the current version of the sensor developed by Pulsify Medical to further guide the development of the device. The data generated will not be used for conformity assessment and this single-center prospective study on 8 patients is therefore deemed appropriate for this purpose.
During the pretreatment visit, eligibility of the subjects for the investigation will be assessed. Once subjects are considered eligible and they have consented to participate in the investigation, the visit to perform the monitoring will be scheduled. An operator will then perform on each patient two scans with the Pulsify sensor. For accurate 3D reconstruction, the ECG and breathing cycle during the acquisition will also be recorded. Immediately after acquisition with the Pulsify sensor, an echocardiographist will record a complete 2D and 3D ultrasound data set using regular ultrasound equipment used for medical examinations in the hospital. The data generated will then be used to compare the accuracy of the Pulsify sensor for cardiac output measurements with state-of-the-art ultrasound. The data will also enable to acquire a dataset of ultrasound images taken with the Pulsify sensor technology in a manner that is very close to the image capture mechanism of Pulsify's final product.
- Conditions
- Cardiac Output Measurements, Healthy Subjects
- Being tested
- Pulsify sensor, State-of-the-art ultrasound equipment
- Keywords
- Ultrasound Cardiac Non-invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsify sensorDevice
A positioning system will move the 1X1 cm Pulsify sensor step-by-step over a marked area of 10x10 cm on the subjects' chest to record a complete 3D data set of the heart. For accurate 3D reconstruction, the ECG and breathing cycle are also recorded during the acquisition using commercially available devices (Bitalino HeartBIT + Respiration Sensor). From the 3D dataset of the heart, the end-systolic and end-diastolic volumes will be extracted automatically to calculate the cardiac output.
State-of-the-art ultrasound equipmentDevice
A complete 2D and 3D ultrasound data set using a GE Vivid E95 ultrasound machine, version 203 (General Electric Healthcare, Chicago, IL, United States) will be recorded. All data will be processed offline with a specialized software packet (EchoPAC, version 203, General Electric Healthcare, Chicago, IL, United States
| Study group | Role | What they receive |
|---|---|---|
| Scan with Pulsify sensor | Experimental | A trained operator will perform on each volunteer two scans with the Pulsify sensor. Both scans will have a different orientation of the sensor. Receives: Device: Pulsify sensor |
| Scan with state-of-the-art ultrasound equipment | Experimental | Immediately after acquisition with the Pulsify sensor, an echocardiographist will record a complete 2D and 3D ultrasound data set using a state-of-the-art equipment. Receives: Device: State-of-the-art ultrasound equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison Cardiac Output
Compare the accuracy of the Pulsify sensor for cardiac output measurements with state-of-the-art ultrasound.
Measured: During procedure (1 hour)
Secondary outcomes (1)
Capture dataset
Acquire a dataset of ultrasound images taken with the Pulsify sensor technology in a manner that is very close to the image capture mechanism of Pulsify's final product. This dataset can be used for further image processing development.
Measured: During procedure (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start19 Oct 2022
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output MeasurementsStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Every subject will first undergo 2 scans with the Pulsify sensor. Immediately after acquisition with the Pulsify sensor, an echocardiographist will record a complete 2D and 3D ultrasound data set using a state-of-the-art equipment.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulsify Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KU Leuven, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
- Investigators
- Alexander Van De Bruaene, Principal investigator, UZ LeuvenLieven Herbots, Principal investigator, Pulsify Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734664
- Sponsor's protocol ID
- FIH_TechDemo1
- Other IDs
- CIV-22-03-03916
- Status last verified
- Jan 2023
- First submitted
- 30 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigational device is new and proprietary technology to Pulsify Medical. Data cannot be shared with others at the moment.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study for the Development of a Novel Ultrasound Transducer Technology Intended for Non-invasive Monitoring of Cardiac Outputs
- ClinicalTrials.gov ID
- NCT05734664
- Acronym / sponsor ID
- FIH_TechDemo1
- Conditions
- Cardiac Output Measurements, Healthy Subjects
- Keywords
- Ultrasound Cardiac Non-invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pulsify MedicalIndustry (pharma, biotech, devices)
- Collaborators
- KU Leuven, Universitaire Ziekenhuizen KU Leuven
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 21 Feb 2023 (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.
Pulsify Medical aims at developing a sensor designed for the non-invasive, continuous and real-time monitoring of cardiac hemodynamics in patients at risk based on new transducer technology and artificial intelligence. It relies on real-time 3D greyscale ultrasound reconstruction of the LV myocardium. This medical device is still under development and the main objective of this clinical investigation is to gather data on the accuracy of the current version of the sensor developed by Pulsify Medical to further guide the development of the device. The data generated will not be used for conformity assessment and this single-center prospective study on 8 patients is therefore deemed appropriate for this purpose.
During the pretreatment visit, eligibility of the subjects for the investigation will be assessed. Once subjects are considered eligible and they have consented to participate in the investigation, the visit to perform the monitoring will be scheduled. An operator will then perform on each patient two scans with the Pulsify sensor. For accurate 3D reconstruction, the ECG and breathing cycle during the acquisition will also be recorded. Immediately after acquisition with the Pulsify sensor, an echocardiographist will record a complete 2D and 3D ultrasound data set using regular ultrasound equipment used for medical examinations in the hospital. The data generated will then be used to compare the accuracy of the Pulsify sensor for cardiac output measurements with state-of-the-art ultrasound. The data will also enable to acquire a dataset of ultrasound images taken with the Pulsify sensor technology in a manner that is very close to the image capture mechanism of Pulsify's final product.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Every subject will first undergo 2 scans with the Pulsify sensor. Immediately after acquisition with the Pulsify sensor, an echocardiographist will record a complete 2D and 3D ultrasound data set using a state-of-the-art equipment.
| Arm | Type | Receives |
|---|---|---|
| Scan with Pulsify sensor | Experimental | Device: Pulsify sensorA trained operator will perform on each volunteer two scans with the Pulsify sensor. Both scans will have a different orientation of the sensor. |
| Scan with state-of-the-art ultrasound equipment | Experimental | Device: State-of-the-art ultrasound equipmentImmediately after acquisition with the Pulsify sensor, an echocardiographist will record a complete 2D and 3D ultrasound data set using a state-of-the-art equipment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- are aged over 18 years old
- have no known cardiovascular diseases
- are willing and able to comply with all investigation related procedures
Key exclusion criteria (7 listed)
- Volunteers with arrhythmias, PM or ICD
- Volunteers with life supporting electronic devices (e.g. pacemakers)
- Volunteers with bad echocardiographic windows
- Volunteers post recent thorax surgery and open chest wounds
- Volunteers with abnormal thorax configuration (COPD, scoliosis, pectus excavatum, etc.) on criteria for the selection of topics
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 |
|---|---|---|
| Pulsify sensorA positioning system will move the 1X1 cm Pulsify sensor step-by-step over a marked area of 10x10 cm on the subjects' chest to record a complete 3D data set of the heart. For accurate 3D reconstruction, the ECG and breathing cycle are also recorded during the acquisition using commercially available devices (Bitalino HeartBIT + Respiration Sensor). From the 3D dataset of the heart, the end-systolic and end-diastolic volumes will be extracted automatically to calculate the cardiac output. | Device | Scan with Pulsify sensor |
| State-of-the-art ultrasound equipmentA complete 2D and 3D ultrasound data set using a GE Vivid E95 ultrasound machine, version 203 (General Electric Healthcare, Chicago, IL, United States) will be recorded. All data will be processed offline with a specialized software packet (EchoPAC, version 203, General Electric Healthcare, Chicago, IL, United States | Device | Scan with state-of-the-art ultrasound equipment |
Primary outcome
Comparison Cardiac Output
Time frame: During procedure (1 hour)
Compare the accuracy of the Pulsify sensor for cardiac output measurements with state-of-the-art ultrasound.
1 secondary outcome
Capture dataset
Time frame: During procedure (1 hour)
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 21 Feb 2023.
- Individual participant dataSharing planned: No. The investigational device is new and proprietary technology to Pulsify Medical. Data cannot be shared with others at the moment.
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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.
Alexander Van De Bruaene principal investigator
UZ Leuven
Lieven Herbots principal investigator
Pulsify Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsify sensor and State-of-the-art ultrasound equipment in people with Cardiac Output Measurements and Healthy Subjects, run by Pulsify Medical at 1 site in Belgium.
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 4 inclusion and 7 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 21 Feb 2023. 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 Belgium. 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?
Comparison Cardiac Output (time frame: During procedure (1 hour)). 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 21 Feb 2023.