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

NCT03148613 | Completed Results FDA Device

• 1 other identifier: CS-401
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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)

Conditions

Smoking, Tobacco

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• User Documentation Assessment With Questionnaire With Observer Ratings

  Up to 90 minutes

• Number of Participants Answering "No" for the Subjective Feedback With Questionnaire

  Up to 90 minutes

• Participant Assessment With Questionnaire Rating Scales

  Up to 90 minutes

Study Arms (2)

18-49 year old smokers using COBSS

OTHER

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

Device: Carbon Monoxide Breath Sensor System (COBSS); Device: Bedfont - Micro+™ Smokerlyzer®

≥50 year old smokers using COBSS

OTHER

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

Device: Carbon Monoxide Breath Sensor System (COBSS); Device: Bedfont - Micro+™ Smokerlyzer®

Interventions

Carbon Monoxide Breath Sensor System (COBSS) DEVICE

Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user.

18-49 year old smokers using COBSS; ≥50 year old smokers using COBSS

Bedfont - Micro+™ Smokerlyzer® DEVICE

Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath.

18-49 year old smokers using COBSS; ≥50 year old smokers using COBSS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• English speaking
• Owns and uses a smartphone
• Willing to sign the Informed Consent Form

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• David Utley, MD: lead
• UserWise, LLC: collaborator

Study Sites (1)

Carrot Sense

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Results Point of Contact

• Title: Director Clinical Affairs
• Organization: Carrot Inc.

craig@carrot.co

650-906-4255

Study Officials

• David Utley, MD

  Pivot Health Technologies Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President and CEO

Model Details: All subjects experience device use compared to a control device (predicate).

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 11, 2017
• Study Start: February 2, 2017
• Primary Completion: March 15, 2017
• Study Completion: August 30, 2017
• Last Updated: October 18, 2022
• Results First Posted: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)