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

David Utley, MD

Status: Completed

Conditions: Smoking, Tobacco

Treatments: Device: Carbon Monoxide Breath Sensor System (COBSS); Device: Bedfont - Micro+™ Smokerlyzer®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03148613

CS-401

Details and patient eligibility

About

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)

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Subject who self-report smoking 2 or more cigarettes each day

Inclusion Criteria:

• 18-80 years of age
• English speaking
• Owns and uses a smartphone
• Willing to sign the Informed Consent Form

Exclusion Criteria:

• Pregnancy

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

18-49 year old smokers using COBSS

Other group

Description:

Younger smokers - Assessment of intended user performance in use scenarios, user documentation assessment, subjective feedback and rating scales. NOTE: 18-49 year Age Arm intended to evaluate human factors and usability of COBSS in younger smokers

Treatment:

Device: Bedfont - Micro+™ Smokerlyzer®

Device: Carbon Monoxide Breath Sensor System (COBSS)

≥50 year old smokers using COBSS

Other group

Description:

Older smokers- Assessment of intended user performance in use scenarios, user documentation assessment, subjective feedback and rating scales. NOTE:≥50 year Age Arm intended to evaluate human factors and usability of COBSS in younger smokers

Treatment:

Device: Bedfont - Micro+™ Smokerlyzer®

Device: Carbon Monoxide Breath Sensor System (COBSS)