NCT03835260

Pivot Breath Sensor Human Factors and Usability Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Jennifer Marler, MD · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Smoking Cessation
• Smoking, Tobacco

Interventions

Type	Name	Description
DEVICE	Pivot Breath Sensor	The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.

Timeline

• Start date: 2019-02-04
• Primary completion: 2019-04-18
• Completion: 2019-04-18
• First posted: 2019-02-08
• Last updated: 2022-11-08
• Results posted: 2022-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study