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Pivot Breath Sensor Human Factors and Usability Study

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ClinicalTrials.gov Identifier: NCT03835260
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
UserWise
Information provided by (Responsible Party):
Jennifer Marler, MD, Carrot Sense

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

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

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pivot Breath Sensor Human Factors and Usability Study
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Pivot Breath Sensor (user group)
Self-reported daily smokers of 2 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.




Primary Outcome Measures :
  1. Human Factors - user performance in use scenarios assessment with observer ratings [ Time Frame: Up to 60 minutes per participant ]

    User performance of participants in intended use scenarios will be assessed at a single visit. Participants will be observed if they can set up the device, use the device and interpret results. Observer ratings include 'Successful' and 'Unsuccessful'. Specific attention will be given to assess if any harms can occur from observed use errors.

    For each participant, the single visit includes 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 60 minutes.

    Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute and assessments will be made over the study session which can last up to 60 minutes.


  2. Human Factors - user documentation assessment with observer ratings [ Time Frame: Up to 60 minutes per participant ]

    Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide and user manual. Observer ratings include 'Successful' and 'Unsuccessful'.

    For each participant, the single visit includes 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 60 minutes.

    Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute each. The User documentation assessment portion of the study session will last up to 30 minutes.


  3. Human Factors - subjective feedback questionnaire [ Time Frame: Up to 60 minutes per participant ]

    Subjective feedback focusing on any concerns on using device will be assessed at single visit. Participants will answer with a Yes or No to the questions.

    For each participant, the single visit includes 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 60 minutes.

    Subjective feedback focusing on any concerns prior to the conclusion of the study session. Subjective feedback questions will take approximately 1-3 minutes each. The Subjective feedback portion of the study session will last up to 5 to 15 minutes.


  4. Human Factors - participant feedback using rating scale [ Time Frame: Up to 60 minutes per participant ]

    Participant will be asked to provide ratings on the following:

    • How would you rate the ease or difficulty using the device?
    • How clear or unclear was the Quick Start Guide?
    • How clear or unclear was the Packaging?
    • How clear or unclear was the User Manual?
    • How easy or difficult was it to understand and interpret the test results?

    The participant will use the following rating scale:

    5 - Very Easy 4 - Easy 3 - Neither Easy nor Difficult 2 - Difficult

    1 - Very difficult

    For each participant, the single visit includes 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 60 minutes.

    Participant will provide the ratings prior to the conclusion of the study session. Participant assessment with questionnaire rating scales will take approximately 1-2 minutes each.




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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
  • 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

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): NCT03835260


Contacts
Contact: Kristine Wong 4155770592 kristine@carrot.co
Contact: Craig Fujii 6509064255 craig@carrot.co

Locations
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: Jennifer Marler, MD         
Sponsors and Collaborators
Jennifer Marler, MD
UserWise
Investigators
Principal Investigator: Jennifer Marler, MD Carrot Sense

Responsible Party: Jennifer Marler, MD, Senior Director, Clinical and Medical Affairs, Carrot Sense
ClinicalTrials.gov Identifier: NCT03835260     History of Changes
Other Study ID Numbers: C-404
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

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