Data Collection Study Using CS (CardiacSense) BP (Blood Pressure) Watch and Pillow Systems

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorCardiacSense Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • CS BP Watch and CS BP Pillow Systems

    Device

    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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: CS BP Watch System and CS BP Pillow SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
day 1, 1 hour

Secondary outcomes

Other outcomes

Sponsors and contacts

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