Blood PressureBPINCT04215185
Data Collection of BP Values by CS6BP
A study testing Arterial LIne in people with Blood Pressure, run by CardiacSense Ltd. at 1 site in Israel.
Trial summary
The primary objective of this research is to collect data to develop an algorithm for continuous, non-inflating measurement of absolute, long-term Blood Pressure using the CS6BP device and to evaluate the safety of the CS6BP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Arterial LIne
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Jul 2020to 15 Jun 2022
- 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
- Age of eighteen (18) year and above
- Ability and willingness to sign an informed consent form
- Monitored by radial arterial line
Who cannot join
- Subjects with hemodynamic support
- Subjects receiving more than 2-3 l of fluid per 24h
- Subjects with septic shock
- Subjects with distal edema
- Subjects with arms trauma, where the watch is not wearable
- Subjects where the radial artery could not be palpate
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- Subjects with life expectancy of less than 24h.
- Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
- Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse, emotional/psychological diagnosis)
Trial locations and contacts
1 site in 1 country.
Liat Shemesh contact
Israel1 site, 1 recruiting
- Recruiting
Sourasky Medical Center
Tel Aviv, 62431
Adi Nimrod, MD, 0524266719, nimroda@tlvmc.gov.il
Adi Nimrod, MD
About this study
Official title: Prospective Open Study for the Development of CS6BP Continuous, Absolute, Non-Inflating Measurement of Blood Pressure
The primary objective of this research is to collect data to develop an algorithm for continuous, non-inflating measurement of absolute, long-term Blood Pressure using the CS6BP device and to evaluate the safety of the CS6BP.
Read the detailed description
The study will take place in the ICU (Intensive Care Unit) on non-anesthetized subjects with an arterial line inserted into the radial artery. The CS6BP non-invasive continuous recording will be collected parallel to an invasive arterial line recording. ECG data that was recorded in the ICU will be collected as well.
The study will include up to 80 subjects.
The subject may be measured by the CS6BP device more than once to check reproducibility. The first measurement may take up to 24h; Subsequent measurements may take up to 5h. All the data analysis will be done offline.
- Conditions
- Blood Pressure
- Being tested
- Arterial LIne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial LIneDevice
Also called A-Line
Continuous non-invasive recording of CS6BP will be taken parallel to the recording of an invasive arterial line. ECG data recorded in the ICU will also be collected.
| Study group | Role | What they receive |
|---|---|---|
| Blood pressure monitor | Experimental | The CS6BP device will be placed on non-anesthetized subjects in the ICU (Intensive Care Unit) with arterial line placement in the radial artery. The first measurement will be for up to 24h; subsequent measures will be up to 5h. Receives: Device: Arterial LIne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of CardiacSense 1BP: Incidence and severity of device related Adverse Events
Incidence and severity of device related Adverse Events
Measured: measurement time (up to 24 hours)
Collection of data from CardicacSense1BP measurements for algorithm development
CardicacSense1BP data will be collected in parallel with blood pressure data from ICU a- line .
Measured: measurement time (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start3 Jul 2020
- Primary completion15 Jun 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Non-anaesthetized subjects in the ICU (Intensive Care Unit) or in the CICU (Cardiac Intensive Care Unit) with arterial line placement in the radial artery.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardiacSense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adi Nimrod, MD, Principal investigator, Director Intensive Care Unit, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215185
- Sponsor's protocol ID
- 004_BPI_DC_OS
- Acronym
- BPI
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2019
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Open Study for the Development of CS6BP Continuous, Absolute, Non-Inflating Measurement of Blood Pressure
- ClinicalTrials.gov ID
- NCT04215185
- Acronym / sponsor ID
- BPI / 004_BPI_DC_OS
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- CardiacSense Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 2 Jan 2020 (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 primary objective of this research is to collect data to develop an algorithm for continuous, non-inflating measurement of absolute, long-term Blood Pressure using the CS6BP device and to evaluate the safety of the CS6BP.
Detailed description
The study will take place in the ICU (Intensive Care Unit) on non-anesthetized subjects with an arterial line inserted into the radial artery. The CS6BP non-invasive continuous recording will be collected parallel to an invasive arterial line recording. ECG data that was recorded in the ICU will be collected as well.
The study will include up to 80 subjects.
The subject may be measured by the CS6BP device more than once to check reproducibility. The first measurement may take up to 24h; Subsequent measurements may take up to 5h. All the data analysis will be done offline.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-anaesthetized subjects in the ICU (Intensive Care Unit) or in the CICU (Cardiac Intensive Care Unit) with arterial line placement in the radial artery.
| Arm | Type | Receives |
|---|---|---|
| Blood pressure monitor | Experimental | Device: Arterial LIneThe CS6BP device will be placed on non-anesthetized subjects in the ICU (Intensive Care Unit) with arterial line placement in the radial artery. The first measurement will be for up to 24h; subsequent measures will be up to 5h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of eighteen (18) year and above
- Ability and willingness to sign an informed consent form
- Monitored by radial arterial line
Key exclusion criteria (9 listed)
- Subjects with hemodynamic support
- Subjects receiving more than 2-3 l of fluid per 24h
- Subjects with septic shock
- Subjects with distal edema
- Subjects with arms trauma, where the watch is not wearable
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 |
|---|---|---|
| Arterial LIneAlso: A-LineContinuous non-invasive recording of CS6BP will be taken parallel to the recording of an invasive arterial line. ECG data recorded in the ICU will also be collected. | Device | Blood pressure monitor |
Primary outcome
Safety of CardiacSense 1BP: Incidence and severity of device related Adverse Events
Time frame: measurement time (up to 24 hours)
Incidence and severity of device related Adverse Events
Collection of data from CardicacSense1BP measurements for algorithm development
Time frame: measurement time (up to 24 hours)
CardicacSense1BP data will be collected in parallel with blood pressure data from ICU a- line .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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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.
Liat Shemesh contact
Adi Nimrod, MD principal investigator
Director Intensive Care Unit, Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial LIne in people with Blood Pressure, run by CardiacSense Ltd. 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 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benita Lanzer (972546861500, benita.lanzer@ocardiacsense.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of CardiacSense 1BP: Incidence and severity of device related Adverse Events (time frame: measurement time (up to 24 hours)). 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 19 Jan 2022.