Blood Pressure MonitoringNCT07749963
Data Collection Study Using CS (CardiacSense) BP (Blood Pressure) Watch and Pillow Systems
A study testing CS BP Watch and CS BP Pillow Systems in people with Blood Pressure Monitoring, run by CardiacSense Ltd. at 1 site in United States.
Trial summary
Collect raw data from CS Watch System, CS BP Pillow System, Arterial line (A-line) and auscultatory cuff measurements in volunteers. The data collected in the study will be used for development of the CS BP algorithms. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Monitoring
- What is being tested?
- CS BP Watch and CS BP Pillow Systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main Inclusion Criteria:
- 50-80 years old.
- Ability and willingness to sign and understand an informed consent form.
- The participant has a palpable radial pulse in both wrists.
- The participant is willing and able to be fitted with the investigational devices, A-line, and reference cuff, and is willing and able to undergo all study procedures, including 1 hour of recording with the investigational devices and A-line.
- Participant has good signal quality with the CS Pillow at both wrists.
- Participant has good PPG signals in both thumbs.
- Participant has good ECG signals using the Watch.
Main Exclusion Criteria:
- Participant who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the participant or interfere with the data collected.
- Participant who has previously participated in a BP study conducted by CardiacSense.
- Participant whose body habitus precludes them from wearing the investigational devices.
- Female participants who self-reported as pregnant based on a urine pregnancy test, or who are self-reported as trying to get pregnant or who are breastfeeding.
- Participant whose BMI is greater than 35.
- Participant with a documented medical history of cardiac arrhythmia or if arrhythmia was detected during the screening.
- Participant with diagnosed diabetes mellitus.
- Participant with implanted cardiac defibrillators or pacemakers, Ventricular Assist Device (VAD) or other mechanical circulatory support devices, whether intracorporal or extracorporeal.
- Participant with stage 4 or stage 5 end-stage renal disease, or participants with arteriovenous shunts.
- Participant with pheochromocytoma or primary hyperaldosteronism.
- Participant with diagnosed heart failure with New York Heart Association (NYHA) class III/IV, or participants with a history of stroke.
- Participant with a known clotting disorders or currently taking a prescription anticoagulants (daily aspirin use is permitted).
- Participant with an infection requiring antibiotics.
- Participant with autonomic dysfunction (such as orthostatic hypotension or neuropathy).
- Participant with peripheral artery disease
- Participants with compromised circulation, including Raynaud's syndrome.
- Participant has a fracture, severe trauma, or anatomical deformity involving the wrist or fingers intended for placement of the investigational devices, which could interfere with proper fitting or function of the devices.
- Participant with moderate to severe valvulopathies.
- Participant with primary vasculitis.
- Participant with tremors or otherwise unable to remain still for 1 hour.
- Participants with changes to their antihypertensive medication regimen, including initiation, discontinuation, or dose modification, within 30 days prior to enrollment.
- The left to right arm lateral difference of the average systolic blood pressure values is more than 15 mmHg or the lateral difference of the average diastolic blood pressure values is more than 10 mmHg.
- Participant belongs to a recruitment category that has already been filled, including BMI category, height category, age group, sex, skin tone category, or blood pressure classification group.
- Participant with contact allergy to ultrasound gel.
- Participant with prior or known allergies to lidocaine (or similar pharmacological agents, e.g. Novocaine).
- Participant with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported).
- Participant with other known health conditions, that might put the participant at risk or might jeopardize the quality of the data collected.
- Participant that fails the modified Allen's test (Perfusion Index Ulnar/Ulnar+Radial Ratio test) (Ratio < 0.4).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Element Boulder Avista Adventist Hospital Plaza
Louisville, Colorado, 80027
Breanna Moylan, 303- 926-5432, breanna.moylan@element.com
Monica Rabanal, FNP, 303- 926-5432, monica.rabanal@element.com
About this study
Official title: A Data Collection Study to Collect Blood Pressure (BP) Data Using the CardiacSense BP Watch and CardiacSense Pillow Systems for Algorithm Development
Collect raw data from CS Watch System, CS BP Pillow System, Arterial line (A-line) and auscultatory cuff measurements in volunteers. The data collected in the study will be used for development of the CS BP algorithms.
Read the detailed description
This is a prospective single-site data collection study designed to collect blood pressure (BP) waveforms and estimate BP via the CardiacSense (CS) BP Watch and CS BP Pillow Systems, in parallel with arterial line (A-line data), auscultatory BP cuff measurements and SpO2 measurements. The data collected will be used for algorithms development of the CS BP Systems.
The study includes a screening phase followed by BP data collection session. Participants will be recruited by the Investigator according to the study eligibility criteria. Each enrolled participant will be fitted with 2 CS BP Watches (one on each hand), a CS BP Pillow, A-line and a cuff for auscultatory BP measurement.
A minimum of 100 participants who meet eligibility criteria will be enrolled in the study. After informed consent is obtained, demographic information, medical history, current medication use, Monk Skin Tone Scale, wrist and bicep circumference measurements and baseline vital signs measurements will be recorded. A modified Allen's test, a lateral difference test using non-invasive cuff auscultatory readings and additional assessments will be performed to confirm eligibility criteria.
In participants who meet the eligibility criteria, study devices (CS BP Watch and CS BP Pillow systems) will be fitted, and an A-line will be inserted into the radial artery. A dynamic response calculation will be performed to confirm the integrity of the inserted line.
After the participant has rested for at least 5 minutes, simultaneous BP recordings using both Watches, the Pillow and the A-line will begin and continue for 1 hour. During the 1-hour recording, a few dual-observer auscultatory BP cuff measurements will be performed on the arm contralateral to the A-line arm by two trained observers.
Upon completion of data collection, all devices will be removed, and adverse events will be assessed and documented.
The end of study for each participant is defined as the completion of device removal and after AE follow up by the study team. The end of the trial is defined as the completion of at least 100 valid participant datasets.
- Conditions
- Blood Pressure Monitoring
- Being tested
- CS BP Watch and CS BP Pillow Systems
- Keywords
- Blood Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS BP Watch and CS BP Pillow SystemsDevice
Also called Arterial Line
The CS BP Watch System is a wrist-worn data acquisition system designed to estimate BP from time-synchronized ECG and PPG signals.
The CS Pillow System estimates BP using a combination of ECG and tonometry signals. The system is comprised of a tonometry-based sensor which is embedded in a biocompatible "pillow" for improved sensitivity and comfort. The Pillow is placed over the pulsatile area of the radial artery using a wristband. Data collected using the CS Watch and CS Pillow Systems will be compared to data collected using Arterial Line and auscultatory BP cuff measurements
| Study group | Role | What they receive |
|---|---|---|
| CS BP Watch System and CS BP Pillow System | Experimental | Data collected from the CS BP Watch and Pillow Systems will be compared to data collected from Arterial Line and auscultatory BP cuff measurements Receives: Device: CS BP Watch and CS BP Pillow Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with complete protocol-defined multi-modal physiological signal acquisition
The primary outcome measure is the number of subjects with complete protocol-defined multi-modal physiological signal acquisition. Multi-modal physiological signal acquisition includes simultaneous recording of: (i) photoplethysmography (PPG); ii) single lead electrocardiography (ECG); iii) tonometry signals from the investigational BP Pillow System ; (iv) continuous invasive arterial blood pressure signals.
Measured: day 1, 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start21 Jul 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure MonitoringStudies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardiacSense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749963
- Sponsor's protocol ID
- 028_BP_DC_US
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Data Collection Study to Collect Blood Pressure (BP) Data Using the CardiacSense BP Watch and CardiacSense Pillow Systems for Algorithm Development
- ClinicalTrials.gov ID
- NCT07749963
- Acronym / sponsor ID
- 028_BP_DC_US
- Conditions
- Blood Pressure Monitoring
- Keywords
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CardiacSense Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 6 Aug 2026 (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.
Collect raw data from CS Watch System, CS BP Pillow System, Arterial line (A-line) and auscultatory cuff measurements in volunteers. The data collected in the study will be used for development of the CS BP algorithms.
Detailed description
This is a prospective single-site data collection study designed to collect blood pressure (BP) waveforms and estimate BP via the CardiacSense (CS) BP Watch and CS BP Pillow Systems, in parallel with arterial line (A-line data), auscultatory BP cuff measurements and SpO2 measurements. The data collected will be used for algorithms development of the CS BP Systems.
The study includes a screening phase followed by BP data collection session. Participants will be recruited by the Investigator according to the study eligibility criteria. Each enrolled participant will be fitted with 2 CS BP Watches (one on each hand), a CS BP Pillow, A-line and a cuff for auscultatory BP measurement.
A minimum of 100 participants who meet eligibility criteria will be enrolled in the study. After informed consent is obtained, demographic information, medical history, current medication use, Monk Skin Tone Scale, wrist and bicep circumference measurements and baseline vital signs measurements will be recorded. A modified Allen's test, a lateral difference test using non-invasive cuff auscultatory readings and additional assessments will be performed to confirm eligibility criteria.
In participants who meet the eligibility criteria, study devices (CS BP Watch and CS BP Pillow systems) will be fitted, and an A-line will be inserted into the radial artery. A dynamic response calculation will be performed to confirm the integrity of the inserted line.
After the participant has rested for at least 5 minutes, simultaneous BP recordings using both Watches, the Pillow and the A-line will begin and continue for 1 hour. During the 1-hour recording, a few dual-observer auscultatory BP cuff measurements will be performed on the arm contralateral to the A-line arm by two trained observers.
Upon completion of data collection, all devices will be removed, and adverse events will be assessed and documented.
The end of study for each participant is defined as the completion of device removal and after AE follow up by the study team. The end of the trial is defined as the completion of at least 100 valid participant datasets.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CS BP Watch System and CS BP Pillow System | Experimental | Device: CS BP Watch and CS BP Pillow SystemsData collected from the CS BP Watch and Pillow Systems will be compared to data collected from Arterial Line and auscultatory BP cuff measurements |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CS BP Watch and CS BP Pillow SystemsAlso: Arterial LineThe CS BP Watch System is a wrist-worn data acquisition system designed to estimate BP from time-synchronized ECG and PPG signals. The CS Pillow System estimates BP using a combination of ECG and tonometry signals. The system is comprised of a tonometry-based sensor which is embedded in a biocompatible "pillow" for improved sensitivity and comfort. The Pillow is placed over the pulsatile area of the radial artery using a wristband. Data collected using the CS Watch and CS Pillow Systems will be compared to data collected using Arterial Line and auscultatory BP cuff measurements | Device | CS BP Watch System and CS BP Pillow System |
Primary outcome
Number of subjects with complete protocol-defined multi-modal physiological signal acquisition
Time frame: day 1, 1 hour
The primary outcome measure is the number of subjects with complete protocol-defined multi-modal physiological signal acquisition. Multi-modal physiological signal acquisition includes simultaneous recording of: (i) photoplethysmography (PPG); ii) single lead electrocardiography (ECG); iii) tonometry signals from the investigational BP Pillow System ; (iv) continuous invasive arterial blood pressure signals.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CS BP Watch and CS BP Pillow Systems in people with Blood Pressure Monitoring, run by CardiacSense Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amarel Boss (+972(54)7970016, amarel@cardiacsense.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with complete protocol-defined multi-modal physiological signal acquisition (time frame: day 1, 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 11 Aug 2026.