Pivot Breath Sensor Performance Study

Pivot Breath Sensor Performance Study

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.

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.

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