Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study

Jennifer Marler, MD

Status: Completed

Conditions: Smoking Reduction; Smoking, Tobacco; Smoking Behaviors; Smoking Cessation

Treatments: Device: Pivot Breath Sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT04133064

c-202

Details and patient eligibility

About

Prospective open label, single center study enrolling up to 220 participants to evaluate the effect of the Pivot Breath Sensor on a user's attitudes towards quitting smoking and smoking behavior.

Full description

Study to collect the following data during and after use of a personal carbon monoxide breath sensor (Pivot Breath Sensor):

• Change in attitudes towards quitting smoking
• Change in smoking behavior
• Participant feedback

Enrollment: 234 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-80 years of age
• Current daily cigarette smokers (at least 10 cigarettes per day)
• Resident of the United States
• Able to read and comprehend English
• Owns and uses a smartphone compatible with the study app (iPhone 5 and above with operating system iOS 11 and above, or, Android 5.0 and above with operating system Android 5.0 and above)
• Willing to sign the Informed Consent Form

Exclusion criteria

• Pregnancy
• Participation in a previous study sponsored by Carrot Inc

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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234 participants in 1 patient group

Pivot Breath Sensor (user group)

Other group

Description:

Self-reported daily smokers of 10 or more cigarettes per day

Treatment:

Device: Pivot Breath Sensor