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
12 participants
OBSERVATIONAL
2017-11-01
2017-11-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Observational
Healthy males and females
Pulse Oximeter
Pulse Oximeter
Interventions
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Pulse Oximeter
Pulse Oximeter
Eligibility Criteria
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Inclusion Criteria
* The subject is of any racial or ethnic group
* The subject is ≥ 30 kg (≥ 66 pounds) in weight (self-reported)
* The subject has at least one finger height of 0.2 - 1.0 inch (based on measurement)
* The subject is between 18 years and 50 years of age (self-reported)
* The subject shows no evidence of medical problems as indicated by satisfactory completion of the health assessment form
* The subject has given written informed consent to participate in the study
* The subject is both willing and able to comply with study procedures.
Exclusion Criteria
* The subject has had any relevant injury at the sensor location site (self-reported)
* The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination)
* The subject is current smoker (self-reported)
* The subject has a known respiratory condition (self-reported)
* The subject has a known heart or cardiovascular condition (self-reported)
* The subject is currently pregnant, is actively trying to get pregnant, or who has a positive urine pregnancy test on the day of the study
* The subject has a clotting disorder (self-reported)
* The subject has Raynaud's Disease (self-reported)
* The subject is known to have a hemoglobinopathy (self-reported)
* The subject is on blood thinners or medication with aspirin (self-reported)
* The subject has unacceptable collateral circulation from the ulnar artery (based on examination)
* The subject is unwilling or unable to provide written informed consent to participate in the study
* The subject is unwilling or unable to comply with the study procedures
* The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
18 Years
50 Years
ALL
Yes
Sponsors
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Nonin Medical, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Dena Raley
Role: STUDY_DIRECTOR
Clinimark, LLC
Locations
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Clinimark
Louisville, Colorado, United States
Countries
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Other Identifiers
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QATP3093
Identifier Type: -
Identifier Source: org_study_id