Pivot Breath Sensor Human Factors and Usability Study

Jennifer Marler, MD

Status: Completed

Conditions: Smoking, Tobacco; Smoking Cessation

Treatments: Device: Pivot Breath Sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03835260

C-404

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Prior experience with a study sponsored by Carrot Inc
• Pregnancy

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Pivot Breath Sensor (user group)

Other group

Description:

Self-reported daily smokers of 2 or more cigarettes per day

Treatment:

Device: Pivot Breath Sensor