Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry
NCT ID: NCT02870179
Last Updated: 2017-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
11 participants
OBSERVATIONAL
2016-08-31
2016-09-30
Brief Summary
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The study is observational in nature which quantifies device performance and accuracy in compassion to a Reference Pulse Oximeter.
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Detailed Description
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A Clinimark 3900 Reference Pulse Oximeter or Nellcor N-600x will be used for the SpO2 calibration. There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population
The Control Pulse Oximeter, GE Healthcare (Datex-Ohmeda) 3900, an FDA cleared device, is used to monitor the oxygen saturation levels real time throughout the study for subject safety and to target stable plateaus. This device is used to assess the stability of the data.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Healthy volunteer
Smoker or non-smoker
Pulse Oximeter
Measurement of physiological parameters
Interventions
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Pulse Oximeter
Measurement of physiological parameters
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
50 Years
ALL
Yes
Sponsors
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Clinimark, LLC
OTHER
Oxitone Medical Ltd.
INDUSTRY
Responsible Party
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Leon Eisen, PhD
Leon Eisen, CEO
Principal Investigators
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Leon Eisen, PhD
Role: PRINCIPAL_INVESTIGATOR
Oxitone Medical Ltd.
Locations
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Clinimark Laboratories
Louisville, Colorado, United States
Countries
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Other Identifiers
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PR 2016-191
Identifier Type: -
Identifier Source: org_study_id
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