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100 Participants NeededMy employer runs this trial

CS BP Watch and Pillow Systems for Hypertension

AB
Overseen ByAmarel Boss
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: CardiacSense Ltd.
Must not be taking: Anticoagulants, Antibiotics
Disqualifiers: Pregnancy, Diabetes, Heart failure, Arrhythmia, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This study is for volunteers willing to have their blood pressure measured using different devices. There are no specific inclusion or exclusion criteria listed, so most adults interested in participating may be eligible.

Inclusion Criteria

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
Participant has good signal quality with the CS Pillow at both wrists
Participant has good PPG signals in both thumbs
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Exclusion Criteria

Participant with implanted cardiac defibrillators, pacemakers, VAD, or other mechanical circulatory support devices
Participant with left to right arm systolic BP difference >15 mmHg or diastolic BP difference >10 mmHg
Participant with prior or known allergies to lidocaine or similar agents
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Data Collection

Participants undergo BP data collection using CS BP Watch, CS BP Pillow, A-line, and auscultatory cuff measurements

1 hour
1 visit (in-person)

Follow-up

Participants are monitored for adverse events and device removal is completed

1 day
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Trial Overview

The trial is collecting blood pressure data from two new devices—the CS BP Watch and CS BP Pillow—along with standard methods like an arterial line and a traditional cuff. The goal is to help improve the accuracy of these new systems.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: CS BP Watch System and CS BP Pillow SystemExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CardiacSense Ltd.

Lead Sponsor

Trials
8
Recruited
390+

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