Smoking CessationNCT03835260

Pivot Breath Sensor Human Factors and Usability Study

A study testing Pivot Breath Sensor in people with Smoking Cessation and Smoking, Tobacco, run by Jennifer Marler, 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, observational open label, single center study enrolling up to 15 subjects to evaluate human factors and usability of the Pivot Breath Sensor. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Smoking Cessation, Smoking, Tobacco
What is being tested?: Pivot Breath Sensor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 4 Feb 2019to 18 Apr 2019
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

Prior experience with a study sponsored by Carrot Inc
Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Carrot Inc.
Redwood City, California, 94063

Other trials in United States

About this study

Prospective, observational open label, single center study enrolling up to 15 subjects to evaluate human factors and usability of the Pivot Breath Sensor.

Read the detailed description

The objectives of this Human Factors/Usability study are to:

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

This human factors and usability testing is conducted to demonstrate that the Pivot Breath Sensor can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions.

Conditions: Smoking Cessation, Smoking, Tobacco
Being tested: Pivot Breath Sensor
Medical subject headings: Smoking Cessation, Tobacco Smoking

What participants receive

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

Pivot Breath SensorDevice
The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.

Study groups in NCT03835260
Study group	Role	What they receive
Pivot Breath Sensor (user group)	Other	Self-reported daily smokers of 2 or more cigarettes per day Receives: Device: Pivot Breath Sensor

What is being measured

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

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.
'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively.
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 60 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 60 minutes.
Measured: Each study session was completed on a single day, for up to 60 minutes. Device set up was assessed at about 5 minutes in. Device use was assessed at about 10 minutes in. Interpretation of results was assessed at about 15 and 20 minutes in.
Human Factors - User Documentation Assessment With Observer Ratings
Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide and user manual. Observer ratings include 'Successful' and 'Unsuccessful'.
'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively.
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 60 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.
Measured: Each study session was completed on a single day, for up to 60 minutes. The user documentation assessment occurred at approximately 30 minutes into the study session.
Human Factors - Subjective Feedback Questionnaire
Subjective feedback focusing on any concerns on using device will be assessed at single visit. Participants will answer with a Yes or No to the questions.
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 60 minutes.
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: Each study session was completed on a single day, for up to 60 minutes. The subjective feedback questionnaire was administered at approximately 40 minutes into the study session.
Human Factors - 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?
- How clear or unclear was the Packaging?
- How clear or unclear was the User Manual?
- How easy or difficult was it to understand and interpret the test results?
The participant will use the following rating scale (higher score = better outcome):
5 - Very Easy 4 - Easy 3 - Neither Easy nor Difficult 2 - Difficult
1 - Very difficult
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 60 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.
Measured: Each study session was completed on a single day, for up to 60 minutes. Participant feedback using a rating scale was provided at approximately 50 minutes into the study session.

Timeline

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

4 Feb 201918 Apr 2019

First posted8 Feb 2019
Study start4 Feb 2019
Primary completion18 Apr 2019
Study completion18 Apr 2019

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 CessationStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03835260
Sponsor's protocol ID: C-404
Status last verified: Oct 2022
First submitted: 4 Feb 2019
Last updated: 8 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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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All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pivot Breath Sensor Human Factors and Usability Study
ClinicalTrials.gov ID: NCT03835260
Acronym / sponsor ID: C-404
Conditions: Smoking Cessation, Smoking, Tobacco
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Jennifer Marler, MDIndustry (pharma, biotech, devices)
Collaborators: UserWise, LLC
Study start: 4 Feb 2019 (actual)
Primary completion: 18 Apr 2019 (actual)
Study completion: 18 Apr 2019 (actual)
First posted: 8 Feb 2019 (actual)
Results: Posted 8 Nov 2022

Clinical summary

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

Prospective, observational open label, single center study enrolling up to 15 subjects to evaluate human factors and usability of the Pivot Breath Sensor.

Detailed description

The objectives of this Human Factors/Usability study are to:

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

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pivot Breath Sensor (user group)	Other	Device: Pivot Breath SensorSelf-reported daily smokers of 2 or more cigarettes per day

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 (2 listed)

Prior experience with a study sponsored by Carrot Inc
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
Pivot Breath SensorThe Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.	Device	Pivot Breath Sensor (user group)

Primary outcome

Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings
Time frame: Each study session was completed on a single day, for up to 60 minutes. Device set up was assessed at about 5 minutes in. Device use was assessed at about 10 minutes in. Interpretation of results was assessed at about 15 and 20 minutes in.
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. 'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively. 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 60 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 60 minutes.
Human Factors - User Documentation Assessment With Observer Ratings
Time frame: Each study session was completed on a single day, for up to 60 minutes. The user documentation assessment occurred at approximately 30 minutes into the study session.
Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide and user manual. Observer ratings include 'Successful' and 'Unsuccessful'. 'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively. 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 60 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.
Human Factors - Subjective Feedback Questionnaire
Time frame: Each study session was completed on a single day, for up to 60 minutes. The subjective feedback questionnaire was administered at approximately 40 minutes into the study session.
Subjective feedback focusing on any concerns on using device will be assessed at single visit. Participants will answer with a Yes or No to the questions. 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 60 minutes. 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.
Human Factors - Participant Feedback Using Rating Scale
Time frame: Each study session was completed on a single day, for up to 60 minutes. Participant feedback using a rating scale was provided at approximately 50 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? * How clear or unclear was the Packaging? * How clear or unclear was the User Manual? * How easy or difficult was it to understand and interpret the test results? The participant will use the following rating scale (higher score = better outcome): 5 - Very Easy 4 - Easy 3 - Neither Easy nor Difficult 2 - Difficult 1 - Very difficult 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 60 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.

Results and safety

Results posted to the registry on 8 Nov 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
Pivot Breath Sensor (User Group)	15	15

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

Time frame: Each study session was completed on a single day, for up to 60 minutes. Device set up was assessed at about 5 minutes in. Device use was assessed at about 10 minutes in. Interpretation of results was assessed at about 15 and 20 minutes in.. Count of participants. Unit: Participants

Measure	Pivot Breath Sensor (User Group) n = 15
Set up device - open packaging: Successful	15
Set up device - open packaging: Unsuccessful	0
Use device: Successful	14
Use device: Unsuccessful	1
Interpret results: Successful	15
Interpret results: Unsuccessful	0

Primary outcome: Human Factors - User Documentation Assessment With Observer Ratings

Time frame: Each study session was completed on a single day, for up to 60 minutes. The user documentation assessment occurred at approximately 30 minutes into the study session.. Count of participants. Unit: Participants

Measure	Pivot Breath Sensor (User Group) n = 15
understanding of the packaging: Successful	15
understanding of the packaging: Unsuccessful	0
understanding of the quick start guide: Successful	14
understanding of the quick start guide: Unsuccessful	1
understanding of the user manual: Successful	15
understanding of the user manual: Unsuccessful	0

Primary outcome: Human Factors - Subjective Feedback Questionnaire

Time frame: Each study session was completed on a single day, for up to 60 minutes. The subjective feedback questionnaire was administered at approximately 40 minutes into the study session.. Count of participants. Unit: Participants

Measure	Pivot Breath Sensor (User Group) n = 15
Dd you experience any moments of hesitation while using the product?: yes	10
Dd you experience any moments of hesitation while using the product?: no	5
Do you have any safety concerns regarding this product or its labeling?: yes	3
Do you have any safety concerns regarding this product or its labeling?: no	12

Primary outcome: Human Factors - Participant Feedback Using Rating Scale

Time frame: Each study session was completed on a single day, for up to 60 minutes. Participant feedback using a rating scale was provided at approximately 50 minutes into the study session.. Count of participants. Unit: Participants

Measure	Pivot Breath Sensor (User Group) n = 15
How would you rate the ease or difficulty of using the device?: very easy/very clear	5
How would you rate the ease or difficulty of using the device?: easy/clear	8
How would you rate the ease or difficulty of using the device?: neither easy/clear nor difficult/unclear	2
How would you rate the ease or difficulty of using the device?: difficult/unclear	0
How would you rate the ease or difficulty of using the device?: very difficult/very unclear	0
How clear or unclear was the Quick Start Guide?: very easy/very clear	8
How clear or unclear was the Quick Start Guide?: easy/clear	6
How clear or unclear was the Quick Start Guide?: neither easy/clear nor difficult/unclear	1

Adverse events

Time frame: Adverse events were observed for throughout the entirety of each participant's study session, up to 60 minutes during a session on one day.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pivot Breath Sensor (User Group)	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Smoking Cessation

Not yet recruitingPhase 3
iCanQuit Smoking Cessation Among Hispanic Adults
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Enrolling by invitationObservational study
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Active, not recruitingEarly Phase 1
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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.

Jennifer Marler, 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 Pivot Breath Sensor in people with Smoking Cessation and Smoking, Tobacco, run by Jennifer Marler, 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 2 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 8 Nov 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 8 Nov 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?

Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings (time frame: Each study session was completed on a single day, for up to 60 minutes. Device set up was assessed at about 5 minutes in. Device use was assessed at about 10 minutes in. Interpretation of results was assessed at about 15 and 20 minutes in.). The study lists 4 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 NCT03835260.

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 8 Nov 2022.