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

NCT05370066 | Unknown

• 2 other identifiers: 007_BPW_DC_OS_BPCL00600
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (2)

• Performance of CS6BP

  Assessment of the performance sensitivity of CS6BP in measuring blood pressure

  up to 1 month

• 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

Study Arms (1)

CS6BP and cuff

EXPERIMENTAL

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.

Interventions

CS6BP watches will be used in the study. DEVICE

CS6BP watches will be used with FDA approved Blood pressure monitors

Also known as: Comparator: Commercially available FDA approved Blood pressure monitors

CS6BP and cuff

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of eighteen (18) year and above
• Ability and willingness to sign an informed consent form

You may not qualify if:

• 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)

Sponsors & Collaborators

• CardiacSense Ltd.: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 62431, Israel

Location

Study Officials

• Jacob giris, MD

  Ichilov Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: open label study
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Data collection for algorithm development CS6BP data will be collected in parallel with commercially available blood pressure monitor measurement.

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: May 11, 2022
• Study Start: December 17, 2020
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)