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

Not Applicable

• Conditions: Blood Pressure
• Interventions: Device: CS6BP watches will be used in the study.

• Registration Number: NCT05370066
• Lead Sponsor: CardiacSense Ltd.

Brief Summary

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.

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 Timeline

• Study Start: 2020-12-17
• Study First Submitted: 2022-04-18
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-06
• Last Update Submitted: 2022-05-06
• Study First Posted: 2022-05-11
• Last Update Posted: 2022-05-11
• Primary Completion: 2023-01-17
• Study Completion: 2023-01-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CS6BP and cuff	CS6BP watches will be used in the study.	CS6BP watches will be used in the study with Commercially available FDA approved Blood pressure monitors:

Primary Outcome Measures

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

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel