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| Name | Class |
|---|---|
| UserWise, LLC | INDUSTRY |
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Prospective, open label, single center clinical study enrolling 70 subjects to study Performance, Human Factors, and Usability for the Carbon Monoxide Breath Sensor System (COBBS)
Performance:
Human Factors and Usability:
NOTES:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18-49 year old smokers using COBSS | Other | Younger smokers - Assessment of intended user performance in use scenarios, user documentation assessment, subjective feedback and rating scales. NOTE: 18-49 year Age Arm intended to evaluate human factors and usability of COBSS in younger smokers |
|
| ≥50 year old smokers using COBSS | Other | Older smokers- Assessment of intended user performance in use scenarios, user documentation assessment, subjective feedback and rating scales. NOTE:≥50 year Age Arm intended to evaluate human factors and usability of COBSS in younger smokers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon Monoxide Breath Sensor System (COBSS) | Device | Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices | CO concentrations in parts per million (ppm) in exhaled breath from subjects at a single visit will be assessed and reported in order to compare the CO measurements from COBSS to a control (predicate) device. The correlation will be reported as an R value. 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 90 minutes. COBSS breath sample will take approximately 1 minute. Breath sample with the control device will take approximately 1 minute. The breath samples will be collected within 5-10 minutes of each other. | 1 minute |
| Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | 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. Outcome measure data table is tally of participants who were 'Successful' in each use scenario. 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 90 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 90 minutes. | 1 minute for each question; up to 90 minutes for study session |
| Measure | Description | Time Frame |
|---|---|---|
| User Documentation Assessment With Questionnaire With Observer Ratings | Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide, reference card, 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 90 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. The 5-Point Likert Scale for Clarity has the following answer options: 5 - Very Clear; 4 - Clear; 3 - Neither Clear nor Unclear; 2 - Unclear; and 1 - Very Unclear. Higher values of this scale represent a better outcome, which is greater clarity/understanding. |
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Subject who self-report smoking 2 or more cigarettes each day
Inclusion Criteria:
Exclusion Criteria:
• Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| David Utley, MD | Pivot Health Technologies Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carrot Sense | Redwood City | California | 94063 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 18-49 Year Old Smokers Using COBSS | Younger smokers - Assessment of intended user performance in use scenarios, user documentation assessment, subjective feedback and rating scales. NOTE: 18-49 year Age Arm intended to evaluate human factors and usability of COBSS in younger smokers Carbon Monoxide Breath Sensor System (COBSS): Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user. Bedfont - Micro+™ Smokerlyzer®: Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath. |
| FG001 | ≥50 Year Old Smokers Using COBSS | Older smokers- Assessment of intended user performance in use scenarios, user documentation assessment, subjective feedback and rating scales. NOTE:≥50 year Age Arm intended to evaluate human factors and usability of COBSS in younger smokers Carbon Monoxide Breath Sensor System (COBSS): Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user. Bedfont - Micro+™ Smokerlyzer®: Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 18-49 Year Old Smokers Using COBSS | Younger smokers - Assessment of intended user performance in use scenarios, user documentation assessment, subjective feedback and rating scales. NOTE: 18-49 year Age Arm intended to evaluate human factors and usability of COBSS in younger smokers Carbon Monoxide Breath Sensor System (COBSS): Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user. Bedfont - Micro+™ Smokerlyzer®: Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices | CO concentrations in parts per million (ppm) in exhaled breath from subjects at a single visit will be assessed and reported in order to compare the CO measurements from COBSS to a control (predicate) device. The correlation will be reported as an R value. 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 90 minutes. COBSS breath sample will take approximately 1 minute. Breath sample with the control device will take approximately 1 minute. The breath samples will be collected within 5-10 minutes of each other. | The performance outcome was designed to evaluate all the participants together, thus the cohorts (arms/groups) were not evaluated separately for this outcome. The cohorts were used for the human factors and usability portion of the study, but are not applicable for this outcome. The R value reported is the correlation coefficient between 70 paired CO measurement values taken with the COBSS and predicate devices, by the 70 participants. | Posted | Number | Correlation coefficient (R-value) | 1 minute |
Adverse events were observed for over the 90 minutes study session for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 18-49 Year Old Smokers Using COBSS | Younger smokers - Assessment of intended user performance in use scenarios, user documentation assessment, subjective feedback and rating scales. NOTE: 18-49 year Age Arm intended to evaluate human factors and usability of COBSS in younger smokers Carbon Monoxide Breath Sensor System (COBSS): Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user. Bedfont - Micro+™ Smokerlyzer®: Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Affairs | Carrot Inc. | 650-906-4255 | craig@carrot.co |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2017 | Sep 14, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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All subjects experience device use compared to a control device (predicate).
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| Bedfont - Micro+™ Smokerlyzer® | Device | Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath. |
|
| Up to 90 minutes |
| Number of Participants Answering "No" for the Subjective Feedback With Questionnaire | Subjective feedback focusing on any concerns (i.e. 'yes', 'no') on using device will be assessed at single visit. 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 90 minutes. *Row title truncated due to character limit. Actual question asked: Were there any points during this portion of the study that you experienced difficulty or had concerns about the product? 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. | Up to 90 minutes |
| Participant Assessment With Questionnaire Rating Scales | Participant will be asked to provide ratings on the following:
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 90 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. The Subjective feedback portion of the study session will last up to 5 minutes. | Up to 90 minutes |
| BG001 | ≥50 Year Old Smokers Using COBSS | Older smokers- Assessment of intended user performance in use scenarios, user documentation assessment, subjective feedback and rating scales. NOTE:≥50 year Age Arm intended to evaluate human factors and usability of COBSS in younger smokers Carbon Monoxide Breath Sensor System (COBSS): Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user. Bedfont - Micro+™ Smokerlyzer®: Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| smoke frequency | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | All Participants | Paired breath samples from each participant Carbon Monoxide Breath Sensor System (COBSS): Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and compared to predicate device Each participant measured carbon monoxide with both the COBSS and the predicate device. These CO measures were paired and used in a regression analysis. |
|
|
| Primary | Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings | 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. Outcome measure data table is tally of participants who were 'Successful' in each use scenario. 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 90 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 90 minutes. | Outcome measure data table is tally of participants who were 'Successful' in each use scenario. | Posted | Count of Participants | Participants | 1 minute for each question; up to 90 minutes for study session |
|
|
|
| Secondary | User Documentation Assessment With Questionnaire With Observer Ratings | Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide, reference card, 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 90 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. The 5-Point Likert Scale for Clarity has the following answer options: 5 - Very Clear; 4 - Clear; 3 - Neither Clear nor Unclear; 2 - Unclear; and 1 - Very Unclear. Higher values of this scale represent a better outcome, which is greater clarity/understanding. | How clear or unclear were the User Manual Reference Card, and Quick Start Guide? | Posted | Count of Participants | Participants | Up to 90 minutes |
|
|
|
| Secondary | Number of Participants Answering "No" for the Subjective Feedback With Questionnaire | Subjective feedback focusing on any concerns (i.e. 'yes', 'no') on using device will be assessed at single visit. 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 90 minutes. *Row title truncated due to character limit. Actual question asked: Were there any points during this portion of the study that you experienced difficulty or had concerns about the product? 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 measure data table is tally of participants answering No. | Posted | Count of Participants | Participants | Up to 90 minutes |
|
|
|
| Secondary | Participant Assessment With Questionnaire Rating Scales | Participant will be asked to provide ratings on the following:
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 90 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. The Subjective feedback portion of the study session will last up to 5 minutes. | Posted | Count of Participants | Participants | Up to 90 minutes |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | ≥50 Year Old Smokers Using COBSS | Older smokers- Assessment of intended user performance in use scenarios, user documentation assessment, subjective feedback and rating scales. NOTE:≥50 year Age Arm intended to evaluate human factors and usability of COBSS in younger smokers Carbon Monoxide Breath Sensor System (COBSS): Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user. Bedfont - Micro+™ Smokerlyzer®: Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | All Participants | Carbon Monoxide Breath Sensor System (COBSS): Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and compared to predicate device | 0 | 70 | 0 | 70 | 0 | 70 |
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| interpret results |
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| 3 - Neither Clear nor Unclear |
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| 2 - Unclear |
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| 1 - Very Unclear |
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| Did you have any safety concerns regarding the product or labeling? |
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| 3 - Neither easy nor difficult |
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| 2 - Difficult |
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| 1 - Very difficult |
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| How easy or difficult was it to understand and interpret the test results? |
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