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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03452280
• Other study ID #: BP1
• Status: Recruiting
• Start date: December 18, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Jade Healthcare Group Inc.
• Contact: Bill Mantzoutsos, MBA
• Phone: 4165666904
• Email: bill.mantzoutsos[@]jhcgi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Locations

Country	Name	City	State
Canada	Alio Health Services Inc.	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Jade Healthcare Group Inc.	Allphase Clinical Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	April 30, 2018
Secondary	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.	April 30, 2018