Pivot Breath Sensor Human Factors and Usability Study

NCT03835260 | Completed Results FDA Device

• 1 other identifier: C-404
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, observational open label, single center study enrolling up to 15 subjects to evaluate human factors and usability of the Pivot Breath Sensor.

Conditions

Smoking Cessation; Smoking, Tobacco

Outcome Measures

Primary Outcomes (4)

• 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. 'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively. 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 60 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 60 minutes.

  Each study session was completed on a single day, for up to 60 minutes. Device set up was assessed at about 5 minutes in. Device use was assessed at about 10 minutes in. Interpretation of results was assessed at about 15 and 20 minutes in.

• Human Factors - User Documentation Assessment With Observer Ratings

  Participant understanding of user documentation will be assessed at single visit. User documentation includes packaging information, quick start guide and user manual. Observer ratings include 'Successful' and 'Unsuccessful'. 'Successful' = user was able to complete the task safely and effectively. Unsuccessful' = user was unable unable to complete the task independently or did not complete the task safely and effectively. 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 60 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.

  Each study session was completed on a single day, for up to 60 minutes. The user documentation assessment occurred at approximately 30 minutes into the study session.

• Human Factors - Subjective Feedback Questionnaire

  Subjective feedback focusing on any concerns on using device will be assessed at single visit. Participants will answer with a Yes or No to the questions. 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 60 minutes. 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.

  Each study session was completed on a single day, for up to 60 minutes. The subjective feedback questionnaire was administered at approximately 40 minutes into the study session.

• Human Factors - Participant Feedback Using Rating Scale

  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? * How clear or unclear was the Packaging? * How clear or unclear was the User Manual? * How easy or difficult was it to understand and interpret the test results? The participant will use the following rating scale (higher score = better outcome): 5 - Very Easy 4 - Easy 3 - Neither Easy nor Difficult 2 - Difficult 1 - Very difficult 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 60 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.

  Each study session was completed on a single day, for up to 60 minutes. Participant feedback using a rating scale was provided at approximately 50 minutes into the study session.

Study Arms (1)

Pivot Breath Sensor (user group)

OTHER

Self-reported daily smokers of 2 or more cigarettes per day

Device: Pivot Breath Sensor

Interventions

Pivot Breath Sensor DEVICE

The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.

Pivot Breath Sensor (user group)

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:

• Prior experience with a study sponsored by Carrot Inc
• Pregnancy

Sponsors & Collaborators

• Jennifer Marler, MD: lead
• UserWise, LLC: collaborator

Study Sites (1)

Carrot Inc.

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Tobacco Use

Results Point of Contact

• Title: Senior Director of Clinical Affairs and Data Science
• Organization: Pivot Health Technologies Inc.

craig@pivot.co

650-906-4255

Study Officials

• Jennifer Marler, MD

  Pivot Health Technologies Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Director, Clinical and Medical Affairs

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 8, 2019
• Study Start: February 4, 2019
• Primary Completion: April 18, 2019
• Study Completion: April 18, 2019
• Last Updated: November 8, 2022
• Results First Posted: November 8, 2022

Record last verified: 2022-10

Locations

US (1)