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Pivot Breath Sensor Performance Study

NCT03870022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-07-01

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • UserWise, LLC

    collaborator INDUSTRY

  • Jennifer Marler, MD

    lead INDUSTRY

Principal Investigators

  • Jen Marler · Pivot Health Technologies Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-04-18
Completion
2019-04-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03870022 on ClinicalTrials.gov