Validation of the JADE wRAP™, a Novel Blood Pressure Measurement Device, Using the Same Arm Sequential Method
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 100
Summary
- Conditions
- Blood Pressure
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 valida...
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.
Tracking Information
- NCT #
- NCT03452280
- Collaborators
- Allphase Clinical Research Inc.
- Investigators
- Principal Investigator: Jeff Smith Alio Health Services Inc.
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