NCT03870022

Pivot Breath Sensor Performance Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Jennifer Marler, MD · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Smoking Cessation
• Smoking, Tobacco

Interventions

Type	Name	Description
DEVICE	Pivot Breath Sensor System	Collect breath sample from the Pivot Breath Sensor to measure the carbon monoxide in the participant's exhaled breath, along with recording responses to user documentation questions and rating scales.
DEVICE	Similar Carbon Monoxide breath sensor system	Collect breath sample from a similar breath sensor to measure the carbon monoxide in the participant's exhaled breath.

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-04-18
• Completion: 2019-04-18
• First posted: 2019-03-11
• Last updated: 2024-07-01
• Results posted: 2022-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study