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Completed

NCT Number: NCT03870022

Pivot Breath Sensor Performance Study

A clinical study enrolling 70 subjects to:

* evaluate the user performance of the Pivot Breath Sensor * compare measurements from the Pivot Breath Sensor to a similar device * assess user documentation comprehension * obtain feedback on the Pivot Breath Sensor via rating scales. No medical decisions will be made related to test results.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Smoking Smoking, Tobacco Tobacco Smoking Tobacco Use

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carrot Inc.

Redwood City, California, 94063, United States

About this study

The objectives of this performance study are to:

  • Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study subjects using two different types of measurement devices.
  • We will assess the correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Inc.) and a similar device.
  • assess user documentation comprehension
  • obtain feedback on the Pivot Breath Sensor via rating scales.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-80 years of age
  • Owns and uses a smartphone
  • Willing to sign the Informed Consent Form
  • Resident of the United States
  • Able to read and comprehend English

Exclusion criteria

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

Treatment and study plan

Pivot Breath Sensor System

Device

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.

Similar Carbon Monoxide breath sensor system

Device

Collect breath sample from a similar breath sensor to measure the carbon monoxide in the participant's exhaled breath.

Primary outcomes

  1. User Performance of Pivot Breath Sensor

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

    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.

  2. Compare Performance of Pivot Breath Sensor With a Similar Device.

    Time frame: 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.

Secondary outcomes

  1. User Documentation Assessment With Observer Ratings

    Time frame: 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.

  2. Participant Feedback Using Rating Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jennifer Marler, MD

Industry

Collaborators

  • UserWise, LLC

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2019
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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