Clinical trial NCT03452280: Validation of the JADE wRAP™, a Novel Blood Pressure Measurement Device, Using the Same Arm Sequential Method
Official title: Validation of the JADE wRAP™, a Novel Blood Pressure Measurement Device, Using the Same Arm Sequential Method
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure
Lead sponsor: Jade Healthcare Group Inc.
Sponsor class: INDUSTRY
Collaborators: name: Allphase Clinical Research Inc.
First posted: 2018-03-02
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Validation Criteria 1
timeFrame: April 30, 2018
Secondary outcomes:
measure: Validation Criteria 2
timeFrame: April 30, 2018
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Alio Health Services Inc.
state: Ontario
Study officials:
affiliation: Alio Health Services Inc.
name: Jeff Smith
role: PRINCIPAL_INVESTIGATOR
References: