Carbon Monoxide Breath Sensor System (COBSS) Performance, Human Factors, and Usability Assessment in a Single Visit
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices
Study Overview
Brief 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)
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:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject who self-report smoking 2 or more cigarettes each day
- •Inclusion Criteria:
- •18-80 years of age
- •English speaking
- •Owns and uses a smartphone
- •Willing to sign the Informed Consent Form
Exclusion Criteria
- •Pregnancy
Arms & Interventions
18-49 year old smokers using COBSS
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
Intervention: Carbon Monoxide Breath Sensor System (COBSS) (Device)
18-49 year old smokers using COBSS
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
Intervention: Bedfont - Micro+™ Smokerlyzer® (Device)
≥50 year old smokers using COBSS
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
Intervention: Carbon Monoxide Breath Sensor System (COBSS) (Device)
≥50 year old smokers using COBSS
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
Intervention: Bedfont - Micro+™ Smokerlyzer® (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- User Documentation Assessment With Questionnaire With Observer Ratings(Up to 90 minutes)
- Participant Assessment With Questionnaire Rating Scales(Up to 90 minutes)
- Number of Participants Answering "No" for the Subjective Feedback With Questionnaire(Up to 90 minutes)
Investigators
David Utley, MD
President and CEO
Pivot Health Technologies Inc.