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

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03452280

BP1

Ages > 18
All Genders
Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Must be at least 18 years of age
Male or Female
Must provide written informed consent prior to the performance of any study-relatedprocedures.

Exclusion

Exclusion Criteria:

Subjects who in the opinion of the study staff are too agitated, distressed or who areotherwise unable to cooperate with study procedures
Subjects with bigeminy, trigeminy, isolated ventricular premature beat (VPD) or atrialfibrillation or any other condition, in the opinion of the study staff that can resultin a significantly irregular heath rhythm.
Subjects with signs or recent history of inflammation or infection of the wrists or atthe reference clinical test site.

Study Design

December 18, 2017

December 31, 2021

Study 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

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.

Connect with a study center

Alio Health Services Inc.
Ottawa, Ontario K2K 2E3
Canada
Active - Recruiting

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