Data Collection Study Using CS BP Pillow System

NCT07635602 | Completed FDA Device

• 1 other identifier: 027_BP_DC_US
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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) continuous invasive arterial blood pressure signals.

  day 1, 1 hour

Study Arms (1)

CS BP Pillow System

EXPERIMENTAL

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

Device: CS BP Pillow System

Interventions

CS BP Pillow System DEVICE

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.

Also known as: Arterial Line

CS BP Pillow System

Eligibility Criteria

• Age: 40 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.

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 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.

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: June 9, 2026

Record last verified: 2026-06

Locations

US (1)