Pivot Breath Sensor Human Factors and Usability Study

• ClinicalTrials.gov Identifier: NCT03835260
• Recruitment Status: Completed
• First Posted: February 8, 2019
• Last Update Posted: October 10, 2019
• Sponsor: Jennifer Marler, MD
• Collaborator: UserWise
• Information provided by (Responsible Party): Jennifer Marler, MD, Carrot Sense

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• 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
• Actual Primary Completion Date: April 18, 2019
• Actual Study Completion Date: April 18, 2019

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, California

Carrot Inc.

Redwood City, California, United States, 94063

Sponsors and Collaborators

Jennifer Marler, MD

UserWise

Investigators

• Principal Investigator: Jennifer Marler, MD; Carrot Sense

More Information

• Responsible Party: Jennifer Marler, MD, Senior Director, Clinical and Medical Affairs, Carrot Sense
• ClinicalTrials.gov Identifier: NCT03835260
• Other Study ID Numbers: C-404
• First Posted: February 8, 2019
• Last Update Posted: October 10, 2019
• Last Verified: October 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes