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Clinical Trial Summary

A clinical study enrolling 70 subjects to: - evaluate the user performance of the Pivot Breath Sensor - compare measurements from the Pivot Breath Sensor to a similar device - assess user documentation comprehension - obtain feedback on the Pivot Breath Sensor via rating scales. No medical decisions will be made related to test results.


Clinical Trial Description

The objectives of this performance study are to: - Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study subjects using two different types of measurement devices. - We will assess the correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Inc.) and a similar device. - assess user documentation comprehension - obtain feedback on the Pivot Breath Sensor via rating scales. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03870022
Study type Interventional
Source Pivot Health Technologies Inc.
Contact
Status Completed
Phase N/A
Start date March 1, 2019
Completion date April 18, 2019

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