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Status unknownNCT03409861Updated Jan 24, 2018

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

An observational study in Blood Pressure, sponsored by Hillel Yaffe Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-24.

Sponsored by Hillel Yaffe Medical Center · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Blood Pressure
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Male and females over the age of 18 years Patients who are already fitted with and invasive Arterial Line (A-Line)

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

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.
04

Study design

Observational model
Other
Time perspective
Other
Enrollment
30 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Blood Pressure Monitoring

    Wearing of a non invasive wristband to measure Blood Pressure

    Time frame: 30-60 seconds of a clean signal from the A-line monitor

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03409861
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
Jan 2018 (estimated)
Primary completion
Jan 2018 (estimated)
Completion
Jan 2018 (estimated)
Last update
Jan 24, 2018

Study contacts

Michal Binebaum
Contact
michal.binenbaum@guardlyff.com
972(0)547299564
Avraham Shotan, Prof
principal investigator · Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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