Status:
UNKNOWN
Validation of the JADE wRAP™, a Novel Blood Pressure Measurement Device, Using the Same Arm Sequential Method
Lead Sponsor:
Jade Healthcare Group Inc.
Collaborating Sponsors:
Allphase Clinical Research Inc.
Conditions:
Blood Pressure
Eligibility:
All Genders
18+ years
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...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 18 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03452280
Start Date
December 18 2017
End Date
December 31 2021
Last Update
February 11 2021
Active Locations (1)
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1
Alio Health Services Inc.
Ottawa, Ontario, Canada, K2K 2E3