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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Smoking, Tobacco
• Intervention / Treatment: Device: Pivot Breath Sensor System; Device: Similar Carbon Monoxide breath sensor system

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Carrot Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 18-80 years of age; Single day study collecting 1 paired breath sample from each subject using two non-invasive breath sampling devices, as well as collecting participant responses to user documentation questions and rating scales.

Device: Pivot Breath Sensor System; 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.; Device: Similar Carbon Monoxide breath sensor system; Collect breath sample from a similar breath sensor to measure the carbon monoxide in the participant's exhaled breath.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Performance of Pivot Breath Sensor	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.	Each study session lasted up to 60 minutes per participant. Use performance was assessed at approximately 10-15 minutes into the study session.
Compare Performance of Pivot Breath Sensor With a Similar Device.	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.	Each study session lasted up to 60 minutes per participant.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Documentation Assessment With Observer Ratings	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.	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 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? 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.	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.

Collaborators and Investigators

• Sponsor: Jennifer Marler, MD
• Collaborators: UserWise, LLC
• Investigators: Principal Investigator: Jen Marler, Pivot Health Technologies Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): April 18, 2019
• Study Completion (Actual): April 18, 2019

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gasotransmitters; Carbon Monoxide
• Other Study ID Numbers: C-150

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No