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Clinical Trial Summary

Prospective, observational open label, single center study enrolling up to 15 subjects to evaluate human factors and usability of the Pivot Breath Sensor.


Clinical Trial Description

The objectives of this Human Factors/Usability study are to: - Ensure that representative intended users are able to operate the Pivot Breath Sensor independently - Validate appropriate mitigations of use related hazards identified in risk management documentation - Uncover previously unforeseen use errors This human factors and usability testing is conducted to demonstrate that the Pivot Breath Sensor can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03835260
Study type Interventional
Source Pivot Health Technologies Inc.
Contact
Status Completed
Phase N/A
Start date February 4, 2019
Completion date April 18, 2019

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