Data Collection Study Using CS BP Pillow System

A Data Collection Study to Collect Blood Pressure Data Using the CardiacSense BP Pillow System for Algorithm Development

Collect raw data from CS BP Pillow System and Arterial line (A-line) in volunteers. The data collected in the study will be used for development of the CS BP algorithm.

Study Overview

• Status: Completed
• Conditions: Blood Pressure Monitoring
• Intervention / Treatment: Device: CS BP Pillow System

Detailed Description

This is a prospective data collection single-site study designed to collect blood pressure (BP) waveforms and estimate BP via the CS BP Pillow System, in parallel with arterial line (A-line data). The data collected will be used for algorithm development of the CS BP system.

The study includes a screening phase followed by BP data collection session using the CS Pillow System and an A-line. Participants will be recruited by the Investigator according to the study eligibility criteria.

A total of 40 participants who meet eligibility criteria will be enrolled in the study in 2 cohorts: Cohort I and Cohort II. Each Cohort will include 20 participants. The cohorts will be identical with respect to study procedures and distribution of sex, body mass index (BMI), age, and blood pressure classification groups.

After informed consent is obtained, demographic information, medical history, current medications use and wrist circumference measurement will be recorded. A modified Allen's test, a lateral difference test and additional assessments will be performed to confirm eligibility criteria. In participants who meet the eligibility criteria, the CS BP Pillow will be placed over the radial artery and an A-line will be inserted into the radial artery of the contralateral hand. 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 the CS BP Pillow System and the A-line will begin and continue for about 1 hour.

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 completion of adverse event follow-up. The end of the study is defined as completion of 40 evaluable participant datasets

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Element Boulder Avista Adventist Hospital Plaza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 40-80 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 device, A-line, and reference cuff, and is willing and able to undergo all study procedures, including 1 hour of recording with the investigational device and A-line.

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 whose body habitus precludes them from wearing the investigational device on their wrist.
• 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.
• 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 peripheral artery disease
• Participants with compromised circulation, including Raynaud's syndrome.
• Participant has a fracture, severe trauma, or anatomical deformity involving the wrist intended for placement of the investigational product, which could interfere with proper fitting or function of the device.
• Participant with moderate to severe valvulopathies.
• Participant with primary vasculitis.
• Participant with tremors or otherwise unable to remain still for 1 hour.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CS BP Pillow System; Data collected from the CS BP Pillow System will be compared to data collected from Arterial Line

Device: CS BP Pillow System; Device: CS Pillow System - The 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 Pillow System will be compared to data collected using Arterial Line.; Other Names: Arterial Line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 1, 1 hour

Collaborators and Investigators

• Sponsor: CardiacSense Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: blood pressure
• Additional Relevant MeSH Terms: Equipment and Supplies; Catheters; Vascular Access Devices
• Other Study ID Numbers: 027_BP_DC_US

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No