Smoking Cessation, Smoking, Tobacco
Conditions
Brief summary
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
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.
Interventions
DEVICEPivot Breath Sensor System
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.
DEVICESimilar Carbon Monoxide breath sensor system
Collect breath sample from a similar breath sensor to measure the carbon monoxide in the participant's exhaled breath.
Sponsors
UserWise, LLC
Jennifer Marler, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| User Performance of Pivot Breath Sensor | Each study session lasted up to 60 minutes per participant. Use performance was assessed at approximately 10-15 minutes into the study session. | 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. |
| Compare Performance of Pivot Breath Sensor With a Similar Device. | Each study session lasted up to 60 minutes per participant. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User Documentation Assessment With Observer Ratings | 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 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. |
| Participant Feedback Using Rating Scale | 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 18-80 Year Old Smokers Smokers aged 18-80 - collection of 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.
Pivot Breath Sensor System: 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.
Bedfont - Micro+™ Smokerlyzer®: Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath.. | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | 18-80 Year Old Smokers |
|---|---|
| Age, Customized Age 18-49 | 34 Participants |
| Age, Customized Age 50-80 | 36 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants |
| Race/Ethnicity, Customized Hawaiian or other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Hispanic, Latino, or Spanish Origin | 6 Participants |
| Race/Ethnicity, Customized White | 44 Participants |
| Region of Enrollment United States | 70 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 40 Participants |
| years smoking | 29.8 years STANDARD_DEVIATION 14.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
Primary
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.
Time frame: Each study session lasted up to 60 minutes per participant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18-80 Year Old Smokers | Compare Performance of Pivot Breath Sensor With a Similar Device. | 0.9710 Correlation coefficient (R-value) |
Primary
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.
Time frame: Each study session lasted up to 60 minutes per participant. Use performance was assessed at approximately 10-15 minutes into the study session.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 18-80 Year Old Smokers | User Performance of Pivot Breath Sensor | Self-training | Successful | 68 Participants |
| 18-80 Year Old Smokers | User Performance of Pivot Breath Sensor | Self-training | Unsuccessful | 2 Participants |
| 18-80 Year Old Smokers | User Performance of Pivot Breath Sensor | Performance breath sample use and/or with use of reference materials | Successful | 70 Participants |
| 18-80 Year Old Smokers | User Performance of Pivot Breath Sensor | Performance breath sample use and/or with use of reference materials | Unsuccessful | 0 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How would you rate the ease or difficulty using the device? | Very Easy | 27 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How would you rate the ease or difficulty using the device? | Easy | 32 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How would you rate the ease or difficulty using the device? | Neither Easy nor Difficult | 9 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How would you rate the ease or difficulty using the device? | Difficult | 2 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How would you rate the ease or difficulty using the device? | Very Difficult | 0 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How would you rate the ease or difficulty using the device? | Not Applicable | 0 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the Quick Start Guide? Why? | Very Easy | 42 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the Quick Start Guide? Why? | Easy | 16 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the Quick Start Guide? Why? | Neither Easy nor Difficult | 6 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the Quick Start Guide? Why? | Difficult | 1 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the Quick Start Guide? Why? | Very Difficult | 0 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the Quick Start Guide? Why? | Not Applicable | 5 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the Packaging? Why? | Very Easy | 54 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the Packaging? Why? | Easy | 12 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the Packaging? Why? | Neither Easy nor Difficult | 3 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the Packaging? Why? | Difficult | 1 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the Packaging? Why? | Very Difficult | 0 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the Packaging? Why? | Not Applicable | 0 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the User Manual on the iPad? Why? | Very Easy | 11 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the User Manual on the iPad? Why? | Easy | 8 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the User Manual on the iPad? Why? | Neither Easy nor Difficult | 2 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the User Manual on the iPad? Why? | Difficult | 2 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the User Manual on the iPad? Why? | Very Difficult | 1 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How clear or unclear was the User Manual on the iPad? Why? | Not Applicable | 46 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | Overall, how clear or unclear were the provided reference materials? Why? | Very Easy | 39 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | Overall, how clear or unclear were the provided reference materials? Why? | Easy | 27 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | Overall, how clear or unclear were the provided reference materials? Why? | Neither Easy nor Difficult | 3 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | Overall, how clear or unclear were the provided reference materials? Why? | Difficult | 1 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | Overall, how clear or unclear were the provided reference materials? Why? | Very Difficult | 0 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | Overall, how clear or unclear were the provided reference materials? Why? | Not Applicable | 0 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How easy or difficult was it to understand and interpret the test results? Why? | Very Easy | 48 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How easy or difficult was it to understand and interpret the test results? Why? | Easy | 16 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How easy or difficult was it to understand and interpret the test results? Why? | Neither Easy nor Difficult | 3 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How easy or difficult was it to understand and interpret the test results? Why? | Difficult | 2 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How easy or difficult was it to understand and interpret the test results? Why? | Very Difficult | 1 Participants |
| 18-80 Year Old Smokers | Participant Feedback Using Rating Scale | How easy or difficult was it to understand and interpret the test results? Why? | Not Applicable | 0 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 18-80 Year Old Smokers | User Documentation Assessment With Observer Ratings | Interpretation of Green CO category after using reference materials | Successful | 69 Participants |
| 18-80 Year Old Smokers | User Documentation Assessment With Observer Ratings | Interpretation of Green CO category after using reference materials | Unsuccessful | 1 Participants |
| 18-80 Year Old Smokers | User Documentation Assessment With Observer Ratings | Interpretation of Orange CO category after using reference materials | Successful | 57 Participants |
| 18-80 Year Old Smokers | User Documentation Assessment With Observer Ratings | Interpretation of Orange CO category after using reference materials | Unsuccessful | 13 Participants |
| 18-80 Year Old Smokers | User Documentation Assessment With Observer Ratings | Interpretation of Red CO category after using reference materials | Successful | 70 Participants |
| 18-80 Year Old Smokers | User Documentation Assessment With Observer Ratings | Interpretation of Red CO category after using reference materials | Unsuccessful | 0 Participants |