Pivot Breath Sensor Performance Study

Jennifer Marler, MD

Status: Completed

Conditions: Smoking, Tobacco; Smoking Cessation

Treatments: Device: Pivot Breath Sensor System; Device: Similar Carbon Monoxide breath sensor system

Study type: Interventional

Funder types: Industry

Identifiers

NCT03870022

C-150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

18-80 years of age

Other group

Description:

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.

Treatment:

Device: Similar Carbon Monoxide breath sensor system

Device: Pivot Breath Sensor System