Trial Outcomes & Findings for Carbon Monoxide Breath Sensor System Performance, Human Factors, and Usability Assessment Conducted in a Single Visit (NCT NCT03148613)

Last Updated: 2022-10-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

1 minute

Results posted on

2022-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	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.	≥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.
Overall Study STARTED	39	31
Overall Study COMPLETED	39	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carbon Monoxide Breath Sensor System Performance, Human Factors, and Usability Assessment Conducted in a Single Visit

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	18-49 Year Old Smokers Using COBSS n=39 Participants 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.	≥50 Year Old Smokers Using COBSS n=31 Participants 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.	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=99 Participants	30 Participants n=107 Participants	69 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Sex: Female, Male Female	18 Participants n=99 Participants	14 Participants n=107 Participants	32 Participants n=206 Participants
Sex: Female, Male Male	21 Participants n=99 Participants	17 Participants n=107 Participants	38 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Black or African American	8 Participants n=99 Participants	9 Participants n=107 Participants	17 Participants n=206 Participants
Race (NIH/OMB) White	16 Participants n=99 Participants	16 Participants n=107 Participants	32 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=99 Participants	3 Participants n=107 Participants	14 Participants n=206 Participants
Region of Enrollment United States	39 participants n=99 Participants	31 participants n=107 Participants	70 participants n=206 Participants
smoke frequency 1 per day	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
smoke frequency 2 - 7 per day	21 Participants n=99 Participants	10 Participants n=107 Participants	31 Participants n=206 Participants
smoke frequency 8 or more per day	16 Participants n=99 Participants	21 Participants n=107 Participants	37 Participants n=206 Participants

PRIMARY outcome

Timeframe: 1 minute

Population: 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.

Outcome measures

Outcome measures
Measure	All Participants n=70 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.	≥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.	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
Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices	0.9878 Correlation coefficient (R-value)	—	—

PRIMARY outcome

Timeframe: 1 minute for each question; up to 90 minutes for study session

Population: Outcome measure data table is tally of participants who were 'Successful' in each use scenario.

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 measures

Outcome measures
Measure	All Participants n=39 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.	≥50 Year Old Smokers Using COBSS n=31 Participants 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.	All Participants n=70 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
Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings set up the device- Pair Breath Sensor	34 Participants	25 Participants	59 Participants
Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings interpret results	38 Participants	31 Participants	69 Participants
Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings use the device - submit a breath sample	37 Participants	29 Participants	66 Participants

SECONDARY outcome

Timeframe: Up to 90 minutes

Population: How clear or unclear were the User Manual Reference Card, and Quick Start Guide?

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.

Outcome measures

Outcome measures
Measure	All Participants n=38 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.	≥50 Year Old Smokers Using COBSS n=31 Participants 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.	All Participants n=69 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
User Documentation Assessment With Questionnaire With Observer Ratings 5 - Very Clear	23 Participants	17 Participants	40 Participants
User Documentation Assessment With Questionnaire With Observer Ratings 4 - Clear	13 Participants	10 Participants	23 Participants
User Documentation Assessment With Questionnaire With Observer Ratings 3 - Neither Clear nor Unclear	2 Participants	1 Participants	3 Participants
User Documentation Assessment With Questionnaire With Observer Ratings 2 - Unclear	0 Participants	2 Participants	2 Participants
User Documentation Assessment With Questionnaire With Observer Ratings 1 - Very Unclear	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 90 minutes

Population: Outcome measure data table is tally of participants answering No.

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 measures

Outcome measures
Measure	All Participants n=38 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.	≥50 Year Old Smokers Using COBSS n=31 Participants 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.	All Participants n=69 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
Number of Participants Answering "No" for the Subjective Feedback With Questionnaire Were there any points during ... that you experienced difficulty or had concerns about the product?*	30 Participants	23 Participants	53 Participants
Number of Participants Answering "No" for the Subjective Feedback With Questionnaire Did you experience any moments of hesitation while using the product?	33 Participants	27 Participants	60 Participants
Number of Participants Answering "No" for the Subjective Feedback With Questionnaire Did you have any safety concerns regarding the product or labeling?	35 Participants	26 Participants	61 Participants

SECONDARY outcome

Timeframe: Up to 90 minutes

Participant will be asked to provide ratings on the following: * How would you rate the ease or difficulty using the device and phone app? 5 - Very Clear; 4 - Clear; 3 - Neither Clear nor Unclear; 2 - Unclear; 1 - Very Unclear * How easy or difficult was it to understand and interpret the test results? 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.

Outcome measures

Outcome measures
Measure	All Participants n=38 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.	≥50 Year Old Smokers Using COBSS n=31 Participants 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.	All Participants n=69 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
Participant Assessment With Questionnaire Rating Scales How would you rate the ease or difficulty using the device and phone app? · 1 - Very difficult	0 Participants	1 Participants	1 Participants
Participant Assessment With Questionnaire Rating Scales How easy or difficult was it to understand and interpret the test results? · 5 - Very Easy	29 Participants	17 Participants	46 Participants
Participant Assessment With Questionnaire Rating Scales How easy or difficult was it to understand and interpret the test results? · 4 - Easy	8 Participants	10 Participants	18 Participants
Participant Assessment With Questionnaire Rating Scales How easy or difficult was it to understand and interpret the test results? · 3 - Neither easy nor difficult	1 Participants	2 Participants	3 Participants
Participant Assessment With Questionnaire Rating Scales How easy or difficult was it to understand and interpret the test results? · 2 - Difficult	0 Participants	2 Participants	2 Participants
Participant Assessment With Questionnaire Rating Scales How easy or difficult was it to understand and interpret the test results? · 1 - Very difficult	0 Participants	0 Participants	0 Participants
Participant Assessment With Questionnaire Rating Scales How would you rate the ease or difficulty using the device and phone app? · 4 - Easy	9 Participants	18 Participants	27 Participants
Participant Assessment With Questionnaire Rating Scales How would you rate the ease or difficulty using the device and phone app? · 5 - Very Easy	26 Participants	8 Participants	34 Participants
Participant Assessment With Questionnaire Rating Scales How would you rate the ease or difficulty using the device and phone app? · 3 - Neither easy nor difficult	3 Participants	2 Participants	5 Participants
Participant Assessment With Questionnaire Rating Scales How would you rate the ease or difficulty using the device and phone app? · 2 - Difficult	0 Participants	2 Participants	2 Participants

Adverse Events

18-49 Year Old Smokers Using COBSS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

≥50 Year Old Smokers Using COBSS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

All Participants

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

Director Clinical Affairs

Carrot Inc.

Phone: 650-906-4255

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place