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

NCT04133064 | Completed Results FDA Device

• 1 other identifier: c-202
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Reduction; Smoking Behaviors; Smoking, Tobacco; Smoking Cessation

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Different Stages of Change in Desire to Quit Smoking

  Assessment of participant's desire to quit by measuring Stage of Change. The participant will be asked if they are serious about quitting smoking and they can select from the following options: * Yes, within the next 30 days * Yes, within the next 6 months * No, not thinking of quitting All data obtained via questionnaires completed by the participants. Throughout the course of the study, if the participant moves from "No, not thinking of quitting" to "yes, within the next 6 months" to "Yes, within the next 30 days" - that is a positive outcome for the participant. If they answered in the reverse, that would be a negative outcome for the participant. In short, becoming more ready to quit is a positive outcome, becoming less ready to quit is a less positive outcome.

  3 months (12 weeks) compared to baseline

• Success to Quit (STQ)

  Assessment of participant's attitudes towards quitting by measuring Success to Quit. The participant will be asked If you were to quit smoking right now, how successful would you be? Rating Scale: 1 = Not at all successful, 10 = Completely successful. Higher score is a better outcome for participants, it indicates a more positive attitude towards quitting smoking.

  3 months (12 weeks)

• Difficulty to Quit (DTQ)

  Assessment of participant's attitudes towards quitting by measuring Perceived Difficulty to staying Quit. Participant will be asked: If you were to quit smoking right now, how difficult do you think it would be to stay smoke free? Rating scale: 1 = Really hard to stay quit, 10 = Really easy to stay quit. Higher score is a better outcome for participants, it indicates a more positive attitude towards quitting smoking, specifically lower perceived difficulty to quit.

  3 months (12 weeks)

• Average Quit Attempts Made Since Using the Pivot Breath Sensor

  Assess participant's smoking behavior by measuring Quit attempts. Participant were asked: Since you began using the Pivot Breath Sensor, how many times have you tried to quit smoking?

  3 months (12 weeks)

• Change in Cigarettes Per Day (CPD) From Baseline

  Assess participant's smoking behavior by measuring CPD. Participant will be asked to enter a number for: How many cigarettes do you now smoke per day, on average? Enter number value.

  3 months (12 weeks)

• Point Prevalence Abstinence (PPA)

  Assess participant's smoking behavior by measuring 7-Day and 30-Day PPA. Participant will be asked: In the last 7 days and 30 days have you smoked any cigarettes? Answer choice: Yes/No 7-Day PPA is defined as answering "No" to "In the last 7 days have you smoked any cigarettes?" 30-Day PPA is defined as answering "No" to "In the last 30 days have you smoked any cigarettes?" Data obtained via questionnaires completed by the participants.

  3 months (12 weeks)

Secondary Outcomes (4)

• Feedback on Breath Sensor Setup, Experience and Use

  1 week

• Feedback on Impact on Motivation to Quit Smoking

  1 week

• Feedback on Impact on Number of Cigarettes Smoked Per Day

  1 week

• Feedback on Commercialization

  4 weeks

Study Arms (1)

Pivot Breath Sensor (user group)

OTHER

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

Device: Pivot Breath Sensor

Interventions

Pivot Breath Sensor DEVICE

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

Pivot Breath Sensor (user group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jennifer Marler, MD: lead

Study Sites (1)

Carrot Inc.

Redwood City, California, 94063, United States

Location

Related Publications (1)

• Marler JD, Fujii CA, Wong KS, Galanko JA, Balbierz DJ, Utley DS. Assessment of a Personal Interactive Carbon Monoxide Breath Sensor in People Who Smoke Cigarettes: Single-Arm Cohort Study. J Med Internet Res. 2020 Oct 2;22(10):e22811. doi: 10.2196/22811.

  PMID: 32894829 DERIVED

MeSH Terms

Conditions

Smoking Reduction; Smoking; Tobacco Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Use

Results Point of Contact

• Title: VP of Clinical and Medical Affairs
• Organization: Pivot Health Technologies Inc.

marler@pivot.co

415-757-7696

Study Officials

• Jen Marler

  Pivot Health Technologies Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Director, Clinical and Medical Affairs

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 21, 2019
• Study Start: September 25, 2019
• Primary Completion: March 10, 2020
• Study Completion: October 1, 2020
• Last Updated: November 9, 2022
• Results First Posted: November 9, 2022

Record last verified: 2022-10

Locations

US (1)