Pivot Breath Sensor Performance Study

NCT ID: NCT03870022

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-04-18

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.

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.

Conditions

Smoking Cessation; Smoking, Tobacco

Study Design

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

Study Groups

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.

Group Type: OTHER

Pivot Breath Sensor System

Intervention Type: 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

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

Jen Marler

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-150

Identifier Type: -

Identifier Source: org_study_id