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

Blood Pressure Clinical Trial

— BPW  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05370066
• Other study ID #: 007_BPW_DC_OS_BP
• Secondary ID: CL00600
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 17, 2020
• Est. completion date: January 17, 2023

Study information

• Verified date: May 2022
• Source: CardiacSense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 17, 2023
• Est. primary completion date: January 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• CS6BP watches will be used in the study.
CS6BP watches will be used with FDA approved Blood pressure monitors

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
CardiacSense Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of CS6BP	Assessment of the performance sensitivity of CS6BP in measuring blood pressure	up to 1 month
Primary	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