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

NCT03452280 | Unknown

• 1 other identifier: BP1
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

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)

  April 30, 2018

Secondary Outcomes (1)

• Validation Criteria 2

  April 30, 2018

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender Distribution * 30% Male * 30% Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Subjects who in the opinion of the study staff are too agitated, distressed or who are otherwise unable to cooperate with study procedures
• 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.
• Subjects with signs or recent history of inflammation or infection of the wrists or at the reference clinical test site.

Sponsors & Collaborators

• Jade Healthcare Group Inc.: lead
• Allphase Clinical Research Inc.: collaborator

Study Sites (1)

Alio Health Services Inc.

Ottawa, Ontario, K2K 2E3, Canada

RECRUITING

Study Officials

• Jeff Smith

  Alio Health Services Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bill Mantzoutsos, MBA

CONTACT

4165666904; bill.mantzoutsos@jhcgi.com

John Babaris

CONTACT

john.babaris@jhcgi.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: December 18, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)