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Pivot Breath Sensor Human Factors and Usability Study

NCT03835260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-11-08

Study results available
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Summary

Prospective, observational open label, single center study enrolling up to 15 subjects to evaluate human factors and usability of the Pivot Breath Sensor.

Conditions

  • Smoking Cessation
  • Smoking, Tobacco

Interventions

DEVICE

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.

Sponsors & Collaborators

  • UserWise, LLC

    collaborator INDUSTRY

  • Jennifer Marler, MD

    lead INDUSTRY

Principal Investigators

  • Jennifer Marler, MD · 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
2019-02-04
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 NCT03835260 on ClinicalTrials.gov