'Wristband Device for the Measurement of Intermittent Blood Pressure and Other Physiological Signals

NCT ID: NCT03409861

Last Updated: 2018-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-01-31

Brief Summary

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A wristband device intended for use as a standalone device, designed for the measurement of intermittent blood pressure, as well as other physiological signals. The device is intended to be worn in day to day life by individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance.

Detailed Description

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The device is intended to be worn on the wrist for intermittent measurements of vital signs such as HR, blood pressure, Skin temperature and activity.

The use does not require any special action from the user apart form wearing the band on either their left or right wrist. The device applies no inflatable mechanics or moving parts. The waistband is watertight and can be worn as any type of bracelet all the time of most of the time.

The study will focus on patients in intensive care or any other cardiology unit who are under continuous oversight of existing Invasive (A-line Gold Standard monitors

Conditions

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Blood Pressure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

1. Signed written Institution approved Informed Consent Form (ICF)
2. Male and Females over the age of 18 years
3. Patients in intensive care or cardiology units who are under continuous oversight of existing Invasive (A-Line) Gold Standard monitors.
4. Only subjects who are fitted with an invasive Arterial Line (A LINE)
5. To the extent possible, individuals who have not been using medication 5 (five) hours prior to the test shall be classified as non-medicated subjects.

Exclusion Criteria

1. Subject who are unable to provide consent
2. Where it would be impractical or inconvenient or otherwise unfeasible to place to place a wristband and generate a signal.
3. Subjects who are not fitted with, or not planned to be fitted with an A-Line during their stay in the hospital.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Avraham Shotan, Prof

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Central Contacts

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Michal Binebaum

Role: CONTACT

972(0)547299564

Other Identifiers

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GuardLyff

Identifier Type: -

Identifier Source: org_study_id

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