Smoking, TobaccoNCT03148613

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

A study testing Carbon Monoxide Breath Sensor System (COBSS) and Bedfont - Micro+™ Smokerlyzer® in people with Smoking, Tobacco, run by David Utley, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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) Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Smoking, Tobacco
What is being tested?: Carbon Monoxide Breath Sensor System (COBSS) and Bedfont - Micro+™ Smokerlyzer®
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: 2 Feb 2017to 30 Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18-80 years of age
English speaking
Owns and uses a smartphone
Willing to sign the Informed Consent Form

Who cannot join

Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Carrot Sense
Redwood City, California, 94063

Other trials in United States

About this study

Official title: Carbon Monoxide Breath Sensor System (COBSS) Performance, Human Factors, and Usability Assessment in a Single Visit

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)

Read the detailed description

Performance:

Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study subjects using two different types of measurement devices.
Assess the correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Sense) and the predicate CO breath sensor (Bedfont).

Human Factors and Usability:

Ensure that representative intended users are able to operate the COBSS independently.
Validate appropriate mitigations of use related hazards identified in risk management documentation.
Uncover previously unforeseen use errors.

NOTES:

The study design allows for the assessment of a performance endpoint and human factors endpoint in a single study.
Each participant will complete the study in a single visit which will include 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.

Conditions: Smoking, Tobacco
Being tested: Carbon Monoxide Breath Sensor System (COBSS), Bedfont - Micro+™ Smokerlyzer®
Medical subject headings: Tobacco Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
Bedfont - Micro+™ Smokerlyzer®Device
Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath.

Study groups in NCT03148613
Study group	Role	What they receive
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 Receives: Device: Carbon Monoxide Breath Sensor System (COBSS); Device: Bedfont - Micro+™ Smokerlyzer®
≥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 Receives: Device: Carbon Monoxide Breath Sensor System (COBSS); Device: Bedfont - Micro+™ Smokerlyzer®

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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.
Measured: 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.
Measured: Up to 90 minutes
Participant Assessment With Questionnaire Rating Scales
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.
Measured: Up to 90 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Feb 201730 Aug 2017

First posted11 May 2017
Study start2 Feb 2017
Primary completion15 Mar 2017
Study completion30 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Smoking, TobaccoStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: All subjects experience device use compared to a control device (predicate).
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03148613
Sponsor's protocol ID: CS-401
Status last verified: Oct 2022
First submitted: 26 Apr 2017
Last updated: 18 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Carbon Monoxide Breath Sensor System (COBSS) Performance, Human Factors, and Usability Assessment in a Single Visit
ClinicalTrials.gov ID: NCT03148613
Acronym / sponsor ID: CS-401
Conditions: Smoking, Tobacco
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: David Utley, MDIndustry (pharma, biotech, devices)
Collaborators: UserWise, LLC
Study start: 2 Feb 2017 (actual)
Primary completion: 15 Mar 2017 (actual)
Study completion: 30 Aug 2017 (actual)
First posted: 11 May 2017 (actual)
Results: Posted 13 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)

Detailed description

Performance:

Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study subjects using two different types of measurement devices.
Assess the correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Sense) and the predicate CO breath sensor (Bedfont).

Human Factors and Usability:

Ensure that representative intended users are able to operate the COBSS independently.
Validate appropriate mitigations of use related hazards identified in risk management documentation.
Uncover previously unforeseen use errors.

NOTES:

The study design allows for the assessment of a performance endpoint and human factors endpoint in a single study.
Each participant will complete the study in a single visit which will include 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.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: All subjects experience device use compared to a control device (predicate).

Arm	Type	Receives
18-49 year old smokers using COBSS	Other	Device: Carbon Monoxide Breath Sensor System (COBSS), Device: Bedfont - Micro+™ Smokerlyzer®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	Device: Carbon Monoxide Breath Sensor System (COBSS), Device: Bedfont - Micro+™ Smokerlyzer®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

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

18-80 years of age
English speaking
Owns and uses a smartphone
Willing to sign the Informed Consent Form

Key exclusion criteria (1 listed)

Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	18-49 year old smokers using COBSS, ≥50 year old smokers using COBSS
Bedfont - Micro+™ Smokerlyzer®Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath.	Device	18-49 year old smokers using COBSS, ≥50 year old smokers using COBSS

Primary outcome

Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices
Time frame: 1 minute
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.
Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings
Time frame: 1 minute for each question; up to 90 minutes for study session
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.

3 secondary outcomes

User Documentation Assessment With Questionnaire With Observer Ratings
Time frame: Up to 90 minutes
Number of Participants Answering "No" for the Subjective Feedback With Questionnaire
Time frame: Up to 90 minutes
Participant Assessment With Questionnaire Rating Scales
Time frame: Up to 90 minutes

Results and safety

Results posted to the registry on 13 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
18-49 Year Old Smokers Using COBSS	39	39
≥50 Year Old Smokers Using COBSS	31	31

Primary outcome: Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices

Time frame: 1 minute. Number. Unit: Correlation coefficient (R-value)

Measure	All Participants n = 70
Value	0.9878

Population analysed: 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.

Primary outcome: Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings

Time frame: 1 minute for each question; up to 90 minutes for study session. Count of participants. Unit: Participants

Measure	18-49 Year Old Smokers Using COBSS n = 39	≥50 Year Old Smokers Using COBSS n = 31	All Participants n = 70
set up the device- Pair Breath Sensor	34	25	59
use the device - submit a breath sample	37	29	66
interpret results	38	31	69

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were observed for over the 90 minutes study session for each participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
18-49 Year Old Smokers Using COBSS	0 of 39 (0%)	0 of 39 (0%)	0 of 39
≥50 Year Old Smokers Using COBSS	0 of 31 (0%)	0 of 31 (0%)	0 of 31
All Participants	0 of 70 (0%)	0 of 70 (0%)	0 of 70

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Utley, MD principal investigator

Pivot Health Technologies Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Carbon Monoxide Breath Sensor System (COBSS) and Bedfont - Micro+™ Smokerlyzer® in people with Smoking, Tobacco, run by David Utley, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices (time frame: 1 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03148613.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.