NCT03148613

Carbon Monoxide Breath Sensor System Performance, Human Factors, and Usability Assessment Conducted in a Single Visit

Carbon Monoxide Breath Sensor System (COBSS) Performance, Human Factors, and Usability Assessment in a Single Visit

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

Summary

Prospective, open label, single center clinical study enrolling 70 subjects to study Performance, Human Factors, and Usability for the Carbon Monoxide Breath Sensor System (COBBS)

Detailed description

Performance: * Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study subjects using two different types of measurement devices. * Assess the correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Sense) and the predicate CO breath sensor (Bedfont). Human Factors and Usability: * Ensure that representative intended users are able to operate the COBSS independently. * Validate appropriate mitigations of use related hazards identified in risk management documentation. * Uncover previously unforeseen use errors. NOTES: * The study design allows for the assessment of a performance endpoint and human factors endpoint in a single study. * Each participant will complete the study in a single visit which will include the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 90 minutes.

Conditions

• Smoking, Tobacco

Interventions

Type	Name	Description
DEVICE	Carbon Monoxide Breath Sensor System (COBSS)	Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user.
DEVICE	Bedfont - Micro+™ Smokerlyzer®	Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath.

Timeline

• Start date: 2017-02-02
• Primary completion: 2017-03-15
• Completion: 2017-08-30
• First posted: 2017-05-11
• Last updated: 2022-10-18
• Results posted: 2022-10-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study