NCT03409861

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

January 3, 2018

Last Update Submit

January 23, 2018

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Signed written Institution approved Informed Consent Form (ICF)
  • Male and Females over the age of 18 years
  • Patients in intensive care or cardiology units who are under continuous oversight of existing Invasive (A-Line) Gold Standard monitors.
  • Only subjects who are fitted with an invasive Arterial Line (A LINE)
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Avraham Shotan, Prof

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Binebaum

CONTACT

972(0)547299564michal.binenbaum@guardlyff.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 24, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 24, 2018

Record last verified: 2018-01