Trial Outcomes & Findings for Pivot Breath Sensor Human Factors and Usability Study (NCT NCT03835260)

Last Updated: 2022-11-08

Results Overview

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. 'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively. 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

Each study session was completed on a single day, for up to 60 minutes. Device set up was assessed at about 5 minutes in. Device use was assessed at about 10 minutes in. Interpretation of results was assessed at about 15 and 20 minutes in.

Results posted on

2022-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Pivot Breath Sensor (User Group) Self-reported daily smokers of 2 or more cigarettes per day 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.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pivot Breath Sensor Human Factors and Usability Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pivot Breath Sensor (User Group) n=15 Participants Self-reported daily smokers of 2 or more cigarettes per day 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.
Age, Customized Age · Age 18-49 years	13 Participants n=5 Participants
Age, Customized Age · Age 49-50 years	2 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	10 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Middle Eastern	2 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Native American	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Other	1 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Daily Smoking Frequency (cigarettes per day) 2-5 cpd	2 Participants n=5 Participants
Daily Smoking Frequency (cigarettes per day) 6-10 cpd	4 Participants n=5 Participants
Daily Smoking Frequency (cigarettes per day) 11-15 cpd	4 Participants n=5 Participants
Daily Smoking Frequency (cigarettes per day) 16+ cpd	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Each study session was completed on a single day, for up to 60 minutes. Device set up was assessed at about 5 minutes in. Device use was assessed at about 10 minutes in. Interpretation of results was assessed at about 15 and 20 minutes in.

Outcome measures

Outcome measures
Measure	Pivot Breath Sensor (User Group) n=15 Participants Self-reported daily smokers of 2 or more cigarettes per day 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.
Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings Set up device - open packaging · Successful	15 Participants
Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings Set up device - open packaging · Unsuccessful	0 Participants
Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings Use device · Successful	14 Participants
Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings Use device · Unsuccessful	1 Participants
Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings Interpret results · Successful	15 Participants
Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings Interpret results · Unsuccessful	0 Participants

PRIMARY outcome

Timeframe: Each study session was completed on a single day, for up to 60 minutes. The user documentation assessment occurred at approximately 30 minutes into the study session.

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'. 'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively. 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.

Outcome measures

Outcome measures
Measure	Pivot Breath Sensor (User Group) n=15 Participants Self-reported daily smokers of 2 or more cigarettes per day 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.
Human Factors - User Documentation Assessment With Observer Ratings understanding of the packaging · Successful	15 Participants
Human Factors - User Documentation Assessment With Observer Ratings understanding of the packaging · Unsuccessful	0 Participants
Human Factors - User Documentation Assessment With Observer Ratings understanding of the quick start guide · Successful	14 Participants
Human Factors - User Documentation Assessment With Observer Ratings understanding of the quick start guide · Unsuccessful	1 Participants
Human Factors - User Documentation Assessment With Observer Ratings understanding of the user manual · Successful	15 Participants
Human Factors - User Documentation Assessment With Observer Ratings understanding of the user manual · Unsuccessful	0 Participants

PRIMARY outcome

Timeframe: Each study session was completed on a single day, for up to 60 minutes. The subjective feedback questionnaire was administered at approximately 40 minutes into the study session.

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.

Outcome measures

Outcome measures
Measure	Pivot Breath Sensor (User Group) n=15 Participants Self-reported daily smokers of 2 or more cigarettes per day 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.
Human Factors - Subjective Feedback Questionnaire Dd you experience any moments of hesitation while using the product? · yes	10 Participants
Human Factors - Subjective Feedback Questionnaire Dd you experience any moments of hesitation while using the product? · no	5 Participants
Human Factors - Subjective Feedback Questionnaire Do you have any safety concerns regarding this product or its labeling? · yes	3 Participants
Human Factors - Subjective Feedback Questionnaire Do you have any safety concerns regarding this product or its labeling? · no	12 Participants

PRIMARY outcome

Timeframe: Each study session was completed on a single day, for up to 60 minutes. Participant feedback using a rating scale was provided at approximately 50 minutes into the study session.

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 (higher score = better outcome): 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.

Outcome measures

Outcome measures
Measure	Pivot Breath Sensor (User Group) n=15 Participants Self-reported daily smokers of 2 or more cigarettes per day 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.
Human Factors - Participant Feedback Using Rating Scale How would you rate the ease or difficulty of using the device? · very easy/very clear	5 Participants
Human Factors - Participant Feedback Using Rating Scale How would you rate the ease or difficulty of using the device? · easy/clear	8 Participants
Human Factors - Participant Feedback Using Rating Scale How would you rate the ease or difficulty of using the device? · neither easy/clear nor difficult/unclear	2 Participants
Human Factors - Participant Feedback Using Rating Scale How would you rate the ease or difficulty of using the device? · difficult/unclear	0 Participants
Human Factors - Participant Feedback Using Rating Scale How would you rate the ease or difficulty of using the device? · very difficult/very unclear	0 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the Quick Start Guide? · very easy/very clear	8 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the Quick Start Guide? · easy/clear	6 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the Quick Start Guide? · neither easy/clear nor difficult/unclear	1 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the Quick Start Guide? · difficult/unclear	0 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the Quick Start Guide? · very difficult/very unclear	0 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the packaging? · very easy/very clear	9 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the packaging? · easy/clear	5 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the packaging? · neither easy/clear nor difficult/unclear	1 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the packaging? · difficult/unclear	0 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the packaging? · very difficult/very unclear	0 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the User Manual on the iPad? · very easy/very clear	11 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the User Manual on the iPad? · easy/clear	4 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the User Manual on the iPad? · neither easy/clear nor difficult/unclear	0 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the User Manual on the iPad? · difficult/unclear	0 Participants
Human Factors - Participant Feedback Using Rating Scale How clear or unclear was the User Manual on the iPad? · very difficult/very unclear	0 Participants
Human Factors - Participant Feedback Using Rating Scale How easy or difficult was it to understand and interpret the test results? · very easy/very clear	5 Participants
Human Factors - Participant Feedback Using Rating Scale How easy or difficult was it to understand and interpret the test results? · easy/clear	8 Participants
Human Factors - Participant Feedback Using Rating Scale How easy or difficult was it to understand and interpret the test results? · neither easy/clear nor difficult/unclear	2 Participants
Human Factors - Participant Feedback Using Rating Scale How easy or difficult was it to understand and interpret the test results? · difficult/unclear	0 Participants
Human Factors - Participant Feedback Using Rating Scale How easy or difficult was it to understand and interpret the test results? · very difficult/very unclear	0 Participants

Adverse Events

Pivot Breath Sensor (User Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Director of Clinical Affairs and Data Science

Pivot Health Technologies Inc.

Phone: 650-906-4255

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place