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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03452280
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : February 11, 2021
Sponsor:
Collaborator:
Allphase Clinical Research Inc.
Information provided by (Responsible Party):
Jade Healthcare Group Inc.

Study Description
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Brief 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.


Condition or disease
Blood Pressure

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Validation of the JADE wRAP™, a Novel Blood Pressure Measurement Device, Using the Same Arm Sequential Method
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Validation Criteria 1 [ Time Frame: April 30, 2018 ]
    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)


Secondary Outcome Measures :
  1. Validation Criteria 2 [ Time Frame: April 30, 2018 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:  

Gender Distribution

  • 30% Male
  • 30% Female
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.
Criteria

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:

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452280


Contacts
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Contact: Bill Mantzoutsos, MBA 4165666904 bill.mantzoutsos@jhcgi.com
Contact: John Babaris john.babaris@jhcgi.com

Locations
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Canada, Ontario
Alio Health Services Inc. Recruiting
Ottawa, Ontario, Canada, K2K 2E3
Contact: Kaytlin Sadler    613-287-2546 ext 322    ksadler@aliohealth.com   
Sponsors and Collaborators
Jade Healthcare Group Inc.
Allphase Clinical Research Inc.
Investigators
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Principal Investigator: Jeff Smith Alio Health Services Inc.
More Information
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Responsible Party: Jade Healthcare Group Inc.
ClinicalTrials.gov Identifier: NCT03452280    
Other Study ID Numbers: BP1
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No