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Status unknownNCT03452280Updated Feb 11, 2021

Validation of the JADE wRAP™, a Novel Blood Pressure Measurement Device, Using the Same Arm Sequential Method

An observational study in Blood Pressure, sponsored by Jade Healthcare Group Inc.. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-11.

Sponsored by Jade Healthcare Group Inc. · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
140
Ages
18 Years and older
Sex
All
01

Study summary

The JADE wRAP™, a wrist worn cuff to measure blood pressure and its supporting software platform is currently at the final alpha prototype stage of development and is not intended for sale.

There are minimal risks with using the JADE wRAP™ device; however, the likelihood of these risks has been reduced through design limitations on electrical power delivered to the device and of the pressure delivered to the cuff portion. Patients should experience little to no discomfort from the inflation of the JADE wRAP™ cuff.

Read the detailed description

The purpose of this study is to validate the JADE wRAP™ in adult patients (≥18 years of age) according to American National Standard, ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type.

The study is intended to be a simple validation of blood pressure parameters only (Systolic and Diastolic). This study is not intended to yield any other special information.

OBJECTIVES

  1. To validate the JADE wRAP™ for systolic and diastolic blood pressures compared to the reference standard mercury sphygmomanometer.

The data collected from this study is for internal purposes only and should assist in further developing the device and supporting platform to a beta stage.

02

Conditions studied

  • Blood Pressure
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

This is a single-center validation study using an auscultatory reference sphygmomanometer (i.e. mercury sphygmomanometer), and shall consist of a minimum of 85 subjects.

Inclusion criteria

  1. Must be at least 18 years of age
  2. Male or Female
  3. Must provide written informed consent prior to the performance of any study-related procedures.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who in the opinion of the study staff are too agitated, distressed or who are otherwise unable to cooperate with study procedures
  2. Subjects with bigeminy, trigeminy, isolated ventricular premature beat (VPD) or atrial fibrillation or any other condition, in the opinion of the study staff that can result in a significantly irregular heath rhythm.
  3. Subjects with signs or recent history of inflammation or infection of the wrists or at the reference clinical test site.
04

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
140 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Validation Criteria 1

    For systolic and diastolic blood pressures, the mean value of the differences of the determinations, of the n individual paired determinations of the JADE wRAPTM and of the observers' determinations with the reference sphygmomanometer for all subjects shall be within or equal to ± 5.0 mmHg (± 0.67 kPa), with a standard deviation, sn, no greater than 8.0 mmHg (1.07 kPa)

    Time frame: April 30, 2018

Secondary outcomes

  1. Validation Criteria 2

    For the systolic and diastolic blood pressures for each of the m subjects, the standard deviation, sm, of the averaged paired determinations per subject of the JADE wRAPTM and of the observers' determinations with the reference sphygmomanometer shall meet the criteria listed.

    Time frame: April 30, 2018

06

Study locations

1 of 1 sites recruiting
  • Alio Health Services Inc.
    Ottawa, Ontario K2K 2E3, Canada
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03452280
Lead sponsor
Jade Healthcare Group Inc.
Collaborators
Allphase Clinical Research Inc.
Responsible party
Sponsor
First posted
Mar 2, 2018
Start date
Dec 18, 2017
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Feb 11, 2021

Study contacts

Bill Mantzoutsos, MBA
Contact
bill.mantzoutsos@jhcgi.com
4165666904
John Babaris
Contact
john.babaris@jhcgi.com
Jeff Smith
principal investigator · Alio Health Services Inc.

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 Feb 2021. You cannot join it, but the record below documents what was studied.

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