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

Blood Pressure Clinical Trial

Official title:

Non-invasive, Non-Oscillometric Blood Pressure Band

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03409861
• Other study ID #: GuardLyff
• Status: Not yet recruiting
• Phase: N/A
• First received: January 3, 2018
• Last updated: January 23, 2018
• Start date: January 2018
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Hillel Yaffe Medical Center
• Contact: Michal Binebaum
• Phone: 972(0)547299564
• Email: michal.binenbaum[@]guardlyff.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Monitoring	Wearing of a non invasive wristband to measure Blood Pressure	30-60 seconds of a clean signal from the A-line monitor