Carbon Monoxide Breath Sensor System Performance, Human Factors, and Usability Assessment Conducted in a Single Visit

Smoking, Tobacco Clinical Trial

Official title:

Carbon Monoxide Breath Sensor System (COBSS) Performance, Human Factors, and Usability Assessment in a Single Visit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148613
• Other study ID #: CS-401
• Status: Completed
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: October 2022
• Source: Pivot Health Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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:

• The study design allows for the assessment of a performance endpoint and human factors endpoint in a single study.

• Each participant will complete the study in a single visit which will include 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 30, 2017
• Est. primary completion date: March 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking, Tobacco

Intervention

Device:
• Carbon Monoxide Breath Sensor System (COBSS)
Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user.
• Bedfont - Micro+™ Smokerlyzer®
Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath.

Locations

Country	Name	City	State
United States	Carrot Sense	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
David Utley, MD	UserWise

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices	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.	1 minute
Primary	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. 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.	1 minute for each question; up to 90 minutes for study session
Secondary	User Documentation Assessment With Questionnaire With Observer Ratings	Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide, reference card, and user manual. Observer ratings include 'Successful' and 'Unsuccessful'.; 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 each. The User documentation assessment portion of the study session will last up to 30 minutes.; The 5-Point Likert Scale for Clarity has the following answer options: 5 - Very Clear; 4 - Clear; 3 - Neither Clear nor Unclear; 2 - Unclear; and 1 - Very Unclear.; Higher values of this scale represent a better outcome, which is greater clarity/understanding.	Up to 90 minutes
Secondary	Number of Participants Answering "No" for the Subjective Feedback With Questionnaire	Subjective feedback focusing on any concerns (i.e. 'yes', 'no') on using device will be assessed at single visit.; 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.; *Row title truncated due to character limit. Actual question asked: Were there any points during this portion of the study that you experienced difficulty or had concerns about the product? 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.	Up to 90 minutes
Secondary	Participant Assessment With Questionnaire Rating Scales	Participant will be asked to provide ratings on the following: How would you rate the ease or difficulty using the device and phone app? 5 - Very Clear; 4 - Clear; 3 - Neither Clear nor Unclear; 2 - Unclear; 1 - Very Unclear; How easy or difficult was it to understand and interpret the test results?; 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.; 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. The Subjective feedback portion of the study session will last up to 5 minutes.	Up to 90 minutes