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| Name | Class |
|---|---|
| UserWise, LLC | INDUSTRY |
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A clinical study enrolling 70 subjects to:
The objectives of this performance study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pivot Breath Sensor System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Each study session lasted up to 60 minutes per participant. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jen Marler | Pivot Health Technologies Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carrot Inc. | Redwood City | California | 94063 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 18-80 Year Old Smokers | Smokers aged 18-80 - collection of 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. Pivot Breath Sensor System: 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. 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 | 18-80 Year Old Smokers | Smokers aged 18-80 - collection of 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. Pivot Breath Sensor System: 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. Bedfont - Micro+™ Smokerlyzer®: Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath.. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | 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. | Posted | Count of Participants | Participants | Each study session lasted up to 60 minutes per participant. Use performance was assessed at approximately 10-15 minutes into the study session. |
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Adverse events were observed for over the 60-minute long 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 | 18-80 Year Old Smokers | Smokers aged 18-80 - collection of 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. Pivot Breath Sensor System: 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. 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 | |
|---|---|---|---|---|
| VP of Clinical and Medical Affairs | Pivot Health Technologies Inc. | 415-757-7696 | marler@pivot.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 26, 2019 | Oct 13, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
| D064424 | Tobacco Use |
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| Similar Carbon Monoxide breath sensor system | Device | Collect breath sample from a similar breath sensor to measure the carbon monoxide in the participant's exhaled breath. |
|
| 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:
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. | 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. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| years smoking | Mean | Standard Deviation | years |
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| Primary | 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. | Posted | Number | Correlation coefficient (R-value) | Each study session lasted up to 60 minutes per participant. |
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|
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| Secondary | 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. | Posted | Count of Participants | Participants | 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. |
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|
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| Secondary | Participant Feedback Using Rating Scale | Participant will be asked to provide ratings on the following:
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. | Posted | Count of Participants | Participants | 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. |
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| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
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| Unsuccessful |
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| Interpretation of Red CO category after using reference materials |
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| Difficult |
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| Very Difficult |
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| Not Applicable |
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| How clear or unclear was the Quick Start Guide? Why? |
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| How clear or unclear was the Packaging? Why? |
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| How clear or unclear was the User Manual on the iPad? Why? |
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| Overall, how clear or unclear were the provided reference materials? Why? |
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| How easy or difficult was it to understand and interpret the test results? Why? |
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