Trial Outcomes & Findings for Pivot Breath Sensor Performance Study (NCT NCT03870022)

Last Updated: 2024-07-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

Each study session lasted up to 60 minutes per participant. Use performance was assessed at approximately 10-15 minutes into the study session.

Results posted on

2024-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	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..
Overall Study STARTED	70
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pivot Breath Sensor Performance Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	18-80 Year Old Smokers n=70 Participants 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..
Age, Customized Age 18-49	34 Participants n=93 Participants
Age, Customized Age 50-80	36 Participants n=93 Participants
Sex: Female, Male Female	30 Participants n=93 Participants
Sex: Female, Male Male	40 Participants n=93 Participants
Race/Ethnicity, Customized White	44 Participants n=93 Participants
Race/Ethnicity, Customized Hispanic, Latino, or Spanish Origin	6 Participants n=93 Participants
Race/Ethnicity, Customized Black or African American	10 Participants n=93 Participants
Race/Ethnicity, Customized Asian	8 Participants n=93 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=93 Participants
Race/Ethnicity, Customized Hawaiian or other Pacific Islander	1 Participants n=93 Participants
Region of Enrollment United States	70 participants n=93 Participants
years smoking	29.8 years STANDARD_DEVIATION 14.8 • n=93 Participants

PRIMARY outcome

Timeframe: Each study session lasted up to 60 minutes per participant. Use performance was assessed at approximately 10-15 minutes into the study session.

Outcome measures

Outcome measures
Measure	18-80 Year Old Smokers n=70 Participants 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..
User Performance of Pivot Breath Sensor Self-training · Unsuccessful	2 Participants
User Performance of Pivot Breath Sensor Self-training · Successful	68 Participants
User Performance of Pivot Breath Sensor Performance breath sample use and/or with use of reference materials · Successful	70 Participants
User Performance of Pivot Breath Sensor Performance breath sample use and/or with use of reference materials · Unsuccessful	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	18-80 Year Old Smokers n=70 Participants 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..
Compare Performance of Pivot Breath Sensor With a Similar Device.	0.9710 Correlation coefficient (R-value)

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	18-80 Year Old Smokers n=70 Participants 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..
User Documentation Assessment With Observer Ratings Interpretation of Orange CO category after using reference materials · Successful	57 Participants
User Documentation Assessment With Observer Ratings Interpretation of Green CO category after using reference materials · Successful	69 Participants
User Documentation Assessment With Observer Ratings Interpretation of Green CO category after using reference materials · Unsuccessful	1 Participants
User Documentation Assessment With Observer Ratings Interpretation of Orange CO category after using reference materials · Unsuccessful	13 Participants
User Documentation Assessment With Observer Ratings Interpretation of Red CO category after using reference materials · Successful	70 Participants
User Documentation Assessment With Observer Ratings Interpretation of Red CO category after using reference materials · Unsuccessful	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	18-80 Year Old Smokers n=70 Participants 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..
Participant Feedback Using Rating Scale How clear or unclear was the Packaging? Why? · Neither Easy nor Difficult	3 Participants
Participant Feedback Using Rating Scale How easy or difficult was it to understand and interpret the test results? Why? · Easy	16 Participants
Participant Feedback Using Rating Scale How easy or difficult was it to understand and interpret the test results? Why? · Difficult	2 Participants
Participant Feedback Using Rating Scale How easy or difficult was it to understand and interpret the test results? Why? · Very Difficult	1 Participants
Participant Feedback Using Rating Scale How would you rate the ease or difficulty using the device? · Very Easy	27 Participants
Participant Feedback Using Rating Scale How would you rate the ease or difficulty using the device? · Easy	32 Participants
Participant Feedback Using Rating Scale How would you rate the ease or difficulty using the device? · Neither Easy nor Difficult	9 Participants
Participant Feedback Using Rating Scale How would you rate the ease or difficulty using the device? · Difficult	2 Participants
Participant Feedback Using Rating Scale How would you rate the ease or difficulty using the device? · Very Difficult	0 Participants
Participant Feedback Using Rating Scale How would you rate the ease or difficulty using the device? · Not Applicable	0 Participants
Participant Feedback Using Rating Scale How clear or unclear was the Quick Start Guide? Why? · Very Easy	42 Participants
Participant Feedback Using Rating Scale How clear or unclear was the Quick Start Guide? Why? · Easy	16 Participants
Participant Feedback Using Rating Scale How clear or unclear was the Quick Start Guide? Why? · Neither Easy nor Difficult	6 Participants
Participant Feedback Using Rating Scale How clear or unclear was the Quick Start Guide? Why? · Difficult	1 Participants
Participant Feedback Using Rating Scale How clear or unclear was the Quick Start Guide? Why? · Very Difficult	0 Participants
Participant Feedback Using Rating Scale How clear or unclear was the Quick Start Guide? Why? · Not Applicable	5 Participants
Participant Feedback Using Rating Scale How clear or unclear was the Packaging? Why? · Very Easy	54 Participants
Participant Feedback Using Rating Scale How clear or unclear was the Packaging? Why? · Easy	12 Participants
Participant Feedback Using Rating Scale How clear or unclear was the Packaging? Why? · Difficult	1 Participants
Participant Feedback Using Rating Scale How clear or unclear was the Packaging? Why? · Very Difficult	0 Participants
Participant Feedback Using Rating Scale How clear or unclear was the Packaging? Why? · Not Applicable	0 Participants
Participant Feedback Using Rating Scale How clear or unclear was the User Manual on the iPad? Why? · Very Easy	11 Participants
Participant Feedback Using Rating Scale How clear or unclear was the User Manual on the iPad? Why? · Easy	8 Participants
Participant Feedback Using Rating Scale How clear or unclear was the User Manual on the iPad? Why? · Neither Easy nor Difficult	2 Participants
Participant Feedback Using Rating Scale How clear or unclear was the User Manual on the iPad? Why? · Difficult	2 Participants
Participant Feedback Using Rating Scale How clear or unclear was the User Manual on the iPad? Why? · Very Difficult	1 Participants
Participant Feedback Using Rating Scale How clear or unclear was the User Manual on the iPad? Why? · Not Applicable	46 Participants
Participant Feedback Using Rating Scale Overall, how clear or unclear were the provided reference materials? Why? · Very Easy	39 Participants
Participant Feedback Using Rating Scale Overall, how clear or unclear were the provided reference materials? Why? · Easy	27 Participants
Participant Feedback Using Rating Scale Overall, how clear or unclear were the provided reference materials? Why? · Neither Easy nor Difficult	3 Participants
Participant Feedback Using Rating Scale Overall, how clear or unclear were the provided reference materials? Why? · Difficult	1 Participants
Participant Feedback Using Rating Scale Overall, how clear or unclear were the provided reference materials? Why? · Very Difficult	0 Participants
Participant Feedback Using Rating Scale Overall, how clear or unclear were the provided reference materials? Why? · Not Applicable	0 Participants
Participant Feedback Using Rating Scale How easy or difficult was it to understand and interpret the test results? Why? · Very Easy	48 Participants
Participant Feedback Using Rating Scale How easy or difficult was it to understand and interpret the test results? Why? · Neither Easy nor Difficult	3 Participants
Participant Feedback Using Rating Scale How easy or difficult was it to understand and interpret the test results? Why? · Not Applicable	0 Participants

Adverse Events

18-80 Year Old Smokers

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

VP of Clinical and Medical Affairs

Pivot Health Technologies Inc.

Phone: 415-757-7696

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place