Smoking CessationNCT03870022
Pivot Breath Sensor Performance Study
A study testing Pivot Breath Sensor System and Similar Carbon Monoxide breath sensor system in people with Smoking Cessation and Smoking, Tobacco, run by Jennifer Marler, MD at 1 site in United States.
Trial 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. 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 System and Similar Carbon Monoxide breath sensor system
- 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
- 1 Mar 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
- Owns and uses a smartphone
- Willing to sign the Informed Consent Form
- Resident of the United States
- Able to read and comprehend English
Who cannot join
- Prior experience with a study sponsored by Carrot Inc.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation, Smoking, Tobacco
- Being tested
- Pivot Breath Sensor System, Similar Carbon Monoxide breath sensor system
- 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 Sensor SystemDevice
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.
Similar Carbon Monoxide breath sensor systemDevice
Collect breath sample from a similar breath sensor to measure the carbon monoxide in the participant's exhaled breath.
| Study group | Role | What they receive |
|---|---|---|
| 18-80 years of age | Other | Single day study collecting 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. Receives: Device: Pivot Breath Sensor System; Device: Similar Carbon Monoxide breath sensor system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each study session lasted up to 60 minutes per participant. Use performance was assessed at approximately 10-15 minutes into the study session.
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.
Measured: Each study session lasted up to 60 minutes per participant.
Secondary outcomes (2)
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.
Measured: 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 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Mar 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Marler, MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UserWise, LLC
- Responsible party
- Sponsor-investigator, Jennifer Marler, MD, Pivot Health Technologies Inc.
- Investigators
- Jen Marler, Principal investigator, Pivot Health Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870022
- Sponsor's protocol ID
- C-150
- Status last verified
- Jun 2024
- First submitted
- 5 Mar 2019
- Last updated
- 1 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivot Breath Sensor Performance Study
- ClinicalTrials.gov ID
- NCT03870022
- Acronym / sponsor ID
- C-150
- Conditions
- Smoking Cessation, Smoking, Tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Jennifer Marler, MDIndustry (pharma, biotech, devices)
- Collaborators
- UserWise, LLC
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Posted 10 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18-80 years of age | Other | Device: Pivot Breath Sensor System, Device: Similar Carbon Monoxide breath sensor systemSingle day study collecting 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
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 Sensor SystemCollect 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. | Device | 18-80 years of age |
| Similar Carbon Monoxide breath sensor systemCollect breath sample from a similar breath sensor to measure the carbon monoxide in the participant's exhaled breath. | Device | 18-80 years of age |
Primary outcome
User Performance of Pivot Breath Sensor
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.
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.
Time frame: 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.
2 secondary outcomes
User Documentation Assessment With Observer Ratings
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.
Participant Feedback Using Rating Scale
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jen Marler 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 System and Similar Carbon Monoxide breath sensor system 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 5 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 1 Jul 2024. 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 10 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?
User Performance of Pivot Breath Sensor (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.). 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?
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 1 Jul 2024.