Blood PressureBPWNCT05370066
Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose Measurement of Blood Pressure
A study testing CS6BP watches will be used in the study. in people with Blood Pressure, run by CardiacSense Ltd. at 1 site in Israel.
Trial summary
This study is performed on hospitalized subjects in the Internal Medicine Division. The study is intended for data collection. The data will be obtained from commercially available blood pressure monitors and simultaneously from the CS6BP watch. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- CS6BP watches will be used in the study.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 17 Dec 2020to 17 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 to 120 years
- 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
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.
About this study
Official title: Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose of Developing Continuous, Absolute, Non-Inflating Measurement of Blood Pressure
This study is performed on hospitalized subjects in the Internal Medicine Division. The study is intended for data collection. The data will be obtained from commercially available blood pressure monitors and simultaneously from the CS6BP watch.
Read the detailed description
This is a prospective open-label study. Hospitalized subjects from Internal Medicine Division will be measured simultaneously with a commercially available blood pressure monitor and CS6BP watch. Subjects may be measured at the clinic or home up to one month following their discharge from the hospital.
Screening:
PI or delegated physician will confirm the eligibility of subjects. Eligible subjects will sign an informed consent form before any study procedure initiation.
Recording session during hospitalization:
Each subject will undergo up to 15 blood pressure measurement sessions during the hospitalization period. The subject will be connected to the CS6BP device and a cuff simultaneously during the session. There will be at least 30 minutes intervals between the end of the session to the beginning of the next session.
Recording session during follow-up:
The study team personnel may schedule up to 10 follow-up visits with the subject at the clinic or the subject's home for three months following discharge from the hospital. Up to 3 measurement sessions will be conducted during each follow-up visit, maintaining 30 minutes intervals between sessions.
In case of participant discomfort or mechanical hindrance from the watch, the medical staff will stop data collection. The subject can ask to remove the watch during data collection.
- Conditions
- Blood Pressure
- Being tested
- CS6BP watches will be used in the study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS6BP watches will be used in the study.Device
Also called Comparator: Commercially available FDA approved Blood pressure monitors
CS6BP watches will be used with FDA approved Blood pressure monitors
| Study group | Role | What they receive |
|---|---|---|
| CS6BP and cuff | Experimental | CS6BP watches will be used in the study with Commercially available FDA approved Blood pressure monitors: Receives: Device: CS6BP watches will be used in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of CS6BP
Assessment of the performance sensitivity of CS6BP in measuring blood pressure
Measured: up to 1 month
Safety Any adverse event observed during the study will be recorded during the study.
Assessment of the safety of using CS6BP for blood pressure measurement
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start17 Dec 2020
- Primary completion17 Jan 2023 (estimated)
- Study completion17 Jan 2023 (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
- Data collection for algorithm development CS6BP data will be collected in parallel with commercially available blood pressure monitor measurement.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardiacSense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob giris, MD, Principal investigator, Ichilov Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370066
- Sponsor's protocol ID
- 007_BPW_DC_OS_BP
- Other IDs
- CL00600
- Acronym
- BPW
- Status last verified
- May 2022
- First submitted
- 18 Apr 2022
- Last updated
- 11 May 2022
- 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 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose of Developing Continuous, Absolute, Non-Inflating Measurement of Blood Pressure
- ClinicalTrials.gov ID
- NCT05370066
- Acronym / sponsor ID
- BPW / 007_BPW_DC_OS_BP
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CardiacSense Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 17 Jan 2023 (estimated)
- Study completion
- 17 Jan 2023 (estimated)
- First posted
- 11 May 2022 (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 study is performed on hospitalized subjects in the Internal Medicine Division. The study is intended for data collection. The data will be obtained from commercially available blood pressure monitors and simultaneously from the CS6BP watch.
Detailed description
This is a prospective open-label study. Hospitalized subjects from Internal Medicine Division will be measured simultaneously with a commercially available blood pressure monitor and CS6BP watch. Subjects may be measured at the clinic or home up to one month following their discharge from the hospital.
Screening:
PI or delegated physician will confirm the eligibility of subjects. Eligible subjects will sign an informed consent form before any study procedure initiation.
Recording session during hospitalization:
Each subject will undergo up to 15 blood pressure measurement sessions during the hospitalization period. The subject will be connected to the CS6BP device and a cuff simultaneously during the session. There will be at least 30 minutes intervals between the end of the session to the beginning of the next session.
Recording session during follow-up:
The study team personnel may schedule up to 10 follow-up visits with the subject at the clinic or the subject's home for three months following discharge from the hospital. Up to 3 measurement sessions will be conducted during each follow-up visit, maintaining 30 minutes intervals between sessions.
In case of participant discomfort or mechanical hindrance from the watch, the medical staff will stop data collection. The subject can ask to remove the watch during data collection.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Data collection for algorithm development CS6BP data will be collected in parallel with commercially available blood pressure monitor measurement.
| Arm | Type | Receives |
|---|---|---|
| CS6BP and cuff | Experimental | Device: CS6BP watches will be used in the study.CS6BP watches will be used in the study with Commercially available FDA approved Blood pressure monitors: |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of eighteen (18) year and above
- Ability and willingness to sign an informed consent form
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 |
|---|---|---|
| CS6BP watches will be used in the study.Also: Comparator: Commercially available FDA approved Blood pressure monitorsCS6BP watches will be used with FDA approved Blood pressure monitors | Device | CS6BP and cuff |
Primary outcome
Performance of CS6BP
Time frame: up to 1 month
Assessment of the performance sensitivity of CS6BP in measuring blood pressure
Safety Any adverse event observed during the study will be recorded during the study.
Time frame: through study completion, an average of 18 months
Assessment of the safety of using CS6BP for blood pressure measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
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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.
Jacob giris, MD principal investigator
Ichilov 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 CS6BP watches will be used in the study. 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 2 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 11 May 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?
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?
Performance of CS6BP (time frame: up to 1 month). 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 11 May 2022.