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Carbon Monoxide Breath Sensor System Performance, Human Factors, and Usability Assessment Conducted in a Single Visit

NCT03148613 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-10-18

Study results available
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Summary

Prospective, open label, single center clinical study enrolling 70 subjects to study Performance, Human Factors, and Usability for the Carbon Monoxide Breath Sensor System (COBBS)

Conditions

  • Smoking, Tobacco

Interventions

DEVICE

Carbon Monoxide Breath Sensor System (COBSS)

Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user.

DEVICE

Bedfont - Micro+™ Smokerlyzer®

Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath.

Sponsors & Collaborators

  • UserWise, LLC

    collaborator INDUSTRY

  • David Utley, MD

    lead INDUSTRY

Principal Investigators

  • David Utley, MD · Pivot Health Technologies Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2017-03-15
Completion
2017-08-30
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 NCT03148613 on ClinicalTrials.gov