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

NCT ID: NCT05370066

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-17
• Study Completion Date: 2023-01-17

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CS6BP and cuff

CS6BP watches will be used in the study with Commercially available FDA approved Blood pressure monitors:

Group Type: EXPERIMENTAL

CS6BP watches will be used in the study.

Intervention Type: DEVICE

CS6BP watches will be used with FDA approved Blood pressure monitors

Interventions

CS6BP watches will be used in the study.

CS6BP watches will be used with FDA approved Blood pressure monitors

Intervention Type: DEVICE

Other Intervention Names

Comparator: Commercially available FDA approved Blood pressure monitors

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardiacSense Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob giris, MD

Role: PRINCIPAL_INVESTIGATOR

Ichilov Medical Center

Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

CL00600

Identifier Type: REGISTRY

Identifier Source: secondary_id

007_BPW_DC_OS_BP

Identifier Type: -

Identifier Source: org_study_id