Pivot Breath Sensor Performance Study

NCT03870022 | Completed Results FDA Device

• 1 other identifier: C-150
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation; Smoking, Tobacco

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• User Documentation Assessment With Observer Ratings

  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

  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.

Study Arms (1)

18-80 years of age

OTHER

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; Device: Similar Carbon Monoxide breath sensor system

Interventions

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.

18-80 years of age

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.

18-80 years of age

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

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: VP of Clinical and Medical Affairs
• Organization: Pivot Health Technologies Inc.

marler@pivot.co

415-757-7696

Study Officials

• Jen Marler

  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: March 5, 2019
• First Posted: March 11, 2019
• Study Start: March 1, 2019
• Primary Completion: April 18, 2019
• Study Completion: April 18, 2019
• Last Updated: July 1, 2024
• Results First Posted: November 10, 2022

Record last verified: 2024-06

Locations

US (1)