Clinical trial NCT05370066: Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose Measurement of Blood Pressure
Official title: Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose of Developing Continuous, Absolute, Non-Inflating Measurement of Blood Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure
Lead sponsor: CardiacSense Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Data collection for algorithm development CS6BP data will be collected in parallel with commercially available blood pressure monitor measurement.
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Performance of CS6BP
timeFrame: up to 1 month
measure: Safety Any adverse event observed during the study will be recorded during the study.
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Ichilov Medical Center
name: Jacob giris, MD
role: PRINCIPAL_INVESTIGATOR
References: