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

Sponsor
CardiacSense Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05370066
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
25
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CS6BP watches will be used in the study.
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Data collection for algorithm development CS6BP data will be collected in parallel with commercially available blood pressure monitor measurement.Data collection for algorithm development CS6BP data will be collected in parallel with commercially available blood pressure monitor measurement.
Masking:
None (Open Label)
Masking Description:
open label study
Primary Purpose:
Other
Official Title:
Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose of Developing Continuous, Absolute, Non-Inflating Measurement of Blood Pressure
Actual Study Start Date :
Dec 17, 2020
Anticipated Primary Completion Date :
Jan 17, 2023
Anticipated Study Completion Date :
Jan 17, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: CS6BP and cuff

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

Device: CS6BP watches will be used in the study.
CS6BP watches will be used with FDA approved Blood pressure monitors
Other Names:
  • Comparator: Commercially available FDA approved Blood pressure monitors

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Performance of CS6BP [up to 1 month]

      Assessment of the performance sensitivity of CS6BP in measuring blood pressure

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tel Aviv Sourasky Medical Center Tel Aviv Israel 62431

    Sponsors and Collaborators

    • CardiacSense Ltd.

    Investigators

    • Principal Investigator: Jacob giris, MD, Ichilov Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CardiacSense Ltd.
    ClinicalTrials.gov Identifier:
    NCT05370066
    Other Study ID Numbers:
    • 007_BPW_DC_OS_BP
    • CL00600
    First Posted:
    May 11, 2022
    Last Update Posted:
    May 11, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 11, 2022