NCT05370066

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: CardiacSense Ltd. · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	CS6BP watches will be used in the study.	CS6BP watches will be used with FDA approved Blood pressure monitors

Timeline

• Start date: 2020-12-17
• Primary completion: 2023-01-17
• Completion: 2023-01-17
• First posted: 2022-05-11
• Last updated: 2022-05-11

Locations

1 site across 1 country: Israel