Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose Measurement of Blood Pressure (BPW)

Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose of Developing Continuous, Absolute, Non-Inflating Measurement of Blood Pressure

This study is performed on hospitalized subjects in the Internal Medicine Division. The study is intended for data collection. The data will be obtained from commercially available blood pressure monitors and simultaneously from the CS6BP watch.

Study Overview

• Status: Active, not recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Device: CS6BP watches will be used in the study.

Detailed Description

This is a prospective open-label study. Hospitalized subjects from Internal Medicine Division will be measured simultaneously with a commercially available blood pressure monitor and CS6BP watch. Subjects may be measured at the clinic or home up to one month following their discharge from the hospital.

Screening:

PI or delegated physician will confirm the eligibility of subjects. Eligible subjects will sign an informed consent form before any study procedure initiation.

Recording session during hospitalization:

Each subject will undergo up to 15 blood pressure measurement sessions during the hospitalization period. The subject will be connected to the CS6BP device and a cuff simultaneously during the session. There will be at least 30 minutes intervals between the end of the session to the beginning of the next session.

Recording session during follow-up:

The study team personnel may schedule up to 10 follow-up visits with the subject at the clinic or the subject's home for three months following discharge from the hospital. Up to 3 measurement sessions will be conducted during each follow-up visit, maintaining 30 minutes intervals between sessions.

In case of participant discomfort or mechanical hindrance from the watch, the medical staff will stop data collection. The subject can ask to remove the watch during data collection.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 62431
    • Tel Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age of eighteen (18) year and above
• Ability and willingness to sign an informed consent form

Exclusion Criteria:

• Subjects with hemodynamic support
• Subjects receiving more than 2-3 l of fluid per 24h
• Subjects with septic shock
• Subjects with distal edema
• Subjects with arms trauma, where the watch is not wearable
• Subjects where the radial artery could not be palpate
• Subjects with life expectancy of less than 24h
• Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
• Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse, emotional/psychological diagnosis)

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: CS6BP and cuff; CS6BP watches will be used in the study with Commercially available FDA approved Blood pressure monitors:	Device: CS6BP watches will be used in the study.; CS6BP watches will be used with FDA approved Blood pressure monitors; Other Names: Comparator: Commercially available FDA approved Blood pressure monitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of CS6BP	Assessment of the performance sensitivity of CS6BP in measuring blood pressure	up to 1 month
Safety Any adverse event observed during the study will be recorded during the study.	Assessment of the safety of using CS6BP for blood pressure measurement	through study completion, an average of 18 months

Collaborators and Investigators

• Sponsor: CardiacSense Ltd.
• Investigators: Principal Investigator: Jacob giris, MD, Ichilov Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Anticipated): January 17, 2023
• Study Completion (Anticipated): January 17, 2023

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 007_BPW_DC_OS_BP; CL00600 (Registry Identifier: MOH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No