Pivot Breath Sensor Performance Study
Status: | Recruiting |
---|---|
Conditions: | Smoking Cessation |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 3/13/2019 |
Start Date: | March 1, 2019 |
End Date: | December 2019 |
Contact: | Kristine Wong |
Email: | kristine@carrot.co |
Phone: | 4155770592 |
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.
- 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.
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.
- 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.
Inclusion Criteria:
- 18-80 years of age
- Owns and uses a smartphone
- Willing to sign the Informed Consent Form
- Resident of the United States
- Able to read and comprehend English
Exclusion Criteria:
- Prior experience with a study sponsored by Carrot Inc.
- Pregnancy
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