Data Collection Study Using CS BP Pillow System

NCT07635602 | Completed FDA Device

• 1 other identifier: 027_BP_DC_US
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Collect raw data from CS BP Pillow System ,CS BP Plate System, IR (Infrared) PPG (Photoplethysmography) sensors and Arterial line (A-line) in volunteers. The data collected in the study will be used for development of the CS BP algorithms.

Conditions

Blood Pressure Monitoring

Keywords

blood pressure

Outcome Measures

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) IR PPG signals (v) continuous invasive arterial blood pressure signals.

  day 1, 1 hour

Study Arms (1)

CS BP Pillow System, CS BP Plate System and IR Pillows

EXPERIMENTAL

Data collected from the systems will be compared to data collected from Arterial Line

Device: CS BP Pillow System, CS BP Plate System and IR Pillows

Interventions

CS BP Pillow System, CS BP Plate System and IR Pillows DEVICE

Device: CS Pillow System CS Pillow System estimates blood pressure using ECG and tonometry signals. It includes a tonometry sensor embedded in a biocompatible pillow, positioned over the radial artery with a wristband for improved sensitivity and comfort and ECG chest wet electrodes fitted on the torso. CS BP Plate System estimates blood pressure using ECG and PPG. The system consists of a handheld, battery-operated Plate with integrated optical and ECG sensors contacted by the thumb. Infrared (IR) Pillow contain a PPG sensor (IR LED and photodiode) embedded in a biocompatible "pillow. The IR Pillow is placed over the radial artery. This sensor enables estimation of arterial compliance, an important factor influencing the blood pressure-blood volume relationship. Data collected using the CS BP Pillow System and the CS Plate System will be compared to data collected using Arterial Line.

Also known as: Arterial Line

CS BP Pillow System, CS BP Plate System and IR Pillows

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The participant was fitted with both CS BP Plate System devices (one for each hand) and CardiacSense technician has determined the measurement quality to be sufficient.

You may not qualify if:

• 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 wrists.
• 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 devices, which could interfere with proper fitting or function of the devices.

Sponsors & Collaborators

• CardiacSense Ltd.: lead

Study Sites (1)

Element Boulder Avista Adventist Hospital Plaza

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Interventions

Vascular Access Devices

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: June 9, 2026
• Study Start: February 10, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-08

Locations

US (1)