Pivot Breath Sensor Human Factors and Usability Study

NCT ID: NCT03835260

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-04
• Study Completion Date: 2019-04-18

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.

Detailed Description

The objectives of this Human Factors/Usability study are to:

• Ensure that representative intended users are able to operate the Pivot Breath Sensor independently
• Validate appropriate mitigations of use related hazards identified in risk management documentation
• Uncover previously unforeseen use errors

This human factors and usability testing is conducted to demonstrate that the Pivot Breath Sensor can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions.

Conditions

Smoking Cessation; Smoking, Tobacco

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pivot Breath Sensor (user group)

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

Group Type: OTHER

Pivot Breath Sensor

Intervention Type: DEVICE

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

Interventions

Pivot Breath Sensor

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18-80 years of age
• English speaking
• Owns and uses a smartphone
• Willing to sign the Informed Consent Form

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UserWise, LLC

INDUSTRY

Sponsor Role: collaborator

Jennifer Marler, MD

INDUSTRY

Sponsor Role: lead

Responsible Party

Jennifer Marler, MD

Senior Director, Clinical and Medical Affairs

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jennifer Marler, MD

Role: PRINCIPAL_INVESTIGATOR

Pivot Health Technologies Inc.

Locations

Carrot Inc.

Redwood City, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

C-404

Identifier Type: -

Identifier Source: org_study_id