Pivot Breath Sensor Performance Study

Study Overview
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Brief Summary
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A clinical study enrolling 70 subjects to: evaluate the user performance of the Pivot Breath Sensor compare measurements from the Pivot Breath Sensor to a similar device assess user documentation comprehension obtain feedback on the Pivot Breath Sensor via rating scales. No medical decisions will be made related to test results.

Detailed Description
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The objectives of this performance study are to: Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study subjects using two different types of measurement devices. We will assess the correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Inc.) and a similar device. assess user documentation comprehension obtain feedback on the Pivot Breath Sensor via rating scales.

Official Title
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Pivot Breath Sensor Performance Study

Conditions
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Smoking Cessation, Smoking, Tobacco

Intervention / Treatment
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* Device: Pivot Breath Sensor System
* Device: Similar Carbon Monoxide breath sensor system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years of age Owns and uses a smartphone Willing to sign the Informed Consent Form Resident of the United States Able to read and comprehend English Exclusion Criteria: Prior experience with a study sponsored by Carrot Inc. Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 18-80 years of age<br>Single day study collecting 1 paired breath sample from each subject using two non-invasive breath sampling devices, as well as collecting participant responses to user documentation questions and rating scales. | Device: Pivot Breath Sensor System<br>* Collect breath sample from the Pivot Breath Sensor to measure the carbon monoxide in the participant's exhaled breath, along with recording responses to user documentation questions and rating scales.<br>Device: Similar Carbon Monoxide breath sensor system<br>* Collect breath sample from a similar breath sensor to measure the carbon monoxide in the participant's exhaled breath.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Performance of Pivot Breath Sensor | Assess user performance of the study device at a single visit. Participants will be observed if they can set up the Pivot Breath Sensor, and whether they can use the device. Observer ratings include 'Successful' and 'Unsuccessful'. Specific attention will be given to assess if any harms can occur from observed use errors. Successful = the participant was able to complete the task independently, safely, effectively, and without difficulty. Unsuccessful = the participant was unable to complete the task independently, safely, effectively, and/or without difficulty. Includes instances where the participant required study moderator assistance. | Each study session lasted up to 60 minutes per participant. Use performance was assessed at approximately 10-15 minutes into the study session. | 
| Compare Performance of Pivot Breath Sensor With a Similar Device. | Compare study device performance with a similar device at a single visit. Participants will then be asked to use a similar CO breath sensor device. The correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Sense) and the similar breath sensor will be assessed. | Each study session lasted up to 60 minutes per participant. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Documentation Assessment With Observer Ratings | Participant understanding of user documentation will be assessed at single visit through interpretation of three different CO test results: green, orange, and red. User documentation used for the interpretation of each result includes: packaging information, quick start guide and user manual. Observer ratings include 'Successful' and 'Unsuccessful'. Successful = the participant was able to complete the task independently, safely, effectively, and without difficulty. Unsuccessful = the participant was unable to complete the task independently, safely, effectively, and/or without difficulty. Includes instances where the participant required study moderator assistance. Participant will be asked to assess the user documentation throughout the study session and will take approximately 10 minutes. | Each study session lasted up to 60 minutes per participant. The user documentation assessment with observer ratings was done between approximately 10 and 35 minutes into the study session. | 
| Participant Feedback Using Rating Scale | 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? Why? How clear or unclear was the Packaging? Why? How clear or unclear was the User Manual on the iPad? Why? Overall, how clear or unclear were the provided reference materials? Why? How easy or difficult was it to understand and interpret the test results? Why? The participant will use the following rating scale: 5 - Very Easy 4 - Easy 3 - Neither Easy nor Difficult 2 - Difficult 1 - Very Difficult Not Applicable 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. | Each study session lasted up to 60 minutes per participant. Use performance was assessed with rating scales at approximately 35 minutes into the study session. |