Data Collection Study Using CS BP Pillow System

Part of paid clinical trials in Louisville, Colorado.

Sponsor
CardiacSense Ltd.
Study ID
NCT07635602
Status
Completed

Conditions

  • Blood Pressure Monitoring

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Jun 9, 2026
Start date
Feb 10, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: CS BP Pillow System, CS BP Plate System and IR Pillows
    Data collected from the systems will be compared to data collected from Arterial Line

Primary Outcome Measure

Number of subjects with complete protocol-defined multi-modal physiological signal acquisition [ Time Frame: day 1, 1 hour ]

Locations (1)

FacilityCityStateZIPSite coordinators
Element Boulder Avista Adventist Hospital PlazaLouisvilleColorado80027-

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By research site
Element Boulder Avista Adventist Hospital Plaza· Louisville, CO

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