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Pivot Breath Sensor Study

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ClinicalTrials.gov Identifier: NCT04133064
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Marler, MD, Carrot Sense

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Reduction Smoking Behaviors Smoking, Tobacco Smoking Cessation Device: Pivot Breath Sensor Not Applicable

Detailed 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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pivot Breath Sensor Study to Evaluate the Effect of the Pivot Breath Sensor on a User's Attitudes Towards Quitting Smoking and Smoking Behavior.
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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Arm Intervention/treatment
Pivot Breath Sensor (user group)
Self-reported daily smokers of 10 or more cigarettes per day
 Device: Pivot Breath Sensor
The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.


Outcome Measures
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Primary Outcome Measures :
  1. Stage of Change [ Time Frame: 3 months ]

    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.

  2. Confidence to Quit [ Time Frame: 3 months ]

    Assessment of participant's attitudes towards quitting by measuring Confidence 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


  3. Difficulty to Quit [ Time Frame: 3 months ]

    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


  4. Quit attempts [ Time Frame: 3 months ]
    Assess participant's smoking behavior by measuring Quit attempts. Participant will be asked: Since you began using the Pivot Breath Sensor, how many times have you tried to quit smoking? Answer choice: Yes/No

  5. Cigarettes Per Day (CPD) [ Time Frame: 3 months ]
    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.

  6. Point Prevalence Abstinence (PPA) [ Time Frame: 3 months ]
    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 Data obtained via questionnaires completed by the participants.


Secondary Outcome Measures :
  1. Feedback on breath sensor setup, experience and use [ Time Frame: 3 months ]

    Gather participant feedback on breath sensor setup:

    Participant is asked:

    1. How would you rate the ease or difficulty of getting started with the breath sensor?
    2. How would you rate the ease or difficulty of following the directions on the breath sensor screen?
    3. If you ever got an error on the breath sensor screen, how easy or difficult was it to understand the issue and correct it?

    Select one:

    1. - Very difficult
    2. - Difficult
    3. - Neither easy nor difficult
    4. - Easy
    5. - Very Easy I did not set up my breath sensor All data obtained via questionnaires completed by the participants.

  2. Feeback on impact [ Time Frame: 3 months ]

    Gather participant feedback on impact of breath sensor:

    Participant will be asked:

    1. How has using the breath sensor affected your motivation to quit smoking?
    2. How has using the breath sensor affected the number of cigarettes you smoke per day?

    Select one:

    • Using the breath sensor has increased my motivation to quit smoking
    • Using the breath sensor has not affected my motivation to quit smoking
    • Using the breath sensor has decreased my motivation to quit smoking
    • I haven't used the breath sensor

  3. Feeback on commercialization [ Time Frame: 3 months ]

    Gather participant feedback on commercialization:

    Participant will be asked:

    1. Hypothetical: if it was commercially available, would you be interested in buying the Pivot Breath Sensor? Answer: Yes/No
    2. What is a reasonable price you would expect to pay for the Pivot Breath Sensor that you have been using (nearest dollar)?


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133064


Contacts
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Contact: Kristine Wong 415-234-0952 kristine@carrot.co
Contact: Craig Fujii 6509064255 craig@carrot.co

Locations
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United States, California
Carrot Inc. Recruiting
Redwood City, California, United States, 94063
Contact: Kristine Wong    415-577-0592    kristine@carrot.co   
Contact: Craig Fujii    6509064255    craig@carrot.co   
Principal Investigator: Jen Marler         
Sponsors and Collaborators
Jennifer Marler, MD
Investigators
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Principal Investigator: Jen Marler Carrot Sense
More Information
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Responsible Party: Jennifer Marler, MD, Senior Director, Clinical and Medical Affairs, Carrot Sense
ClinicalTrials.gov Identifier: NCT04133064     History of Changes
Other Study ID Numbers: c-202
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No