Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility
NCT ID: NCT03128853
Last Updated: 2020-04-27
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
NA
57 participants
INTERVENTIONAL
2016-10-31
2016-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Test subjects
Each subject receives the Rad-67 and DCI Mini sensor that will measure hemoglobin repeatedly in order to compare those measurements against a blood sample reference.
Rad-67 and DCI Mini Sensor
Interventions
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Rad-67 and DCI Mini Sensor
Eligibility Criteria
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Inclusion Criteria
* Weight greater than or equal to 3 kg
* The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
Exclusion Criteria
* Decision-impaired adult on behalf of a pediatric patient who is unable to assent
* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
* Subjects deemed not suitable for the study at the discretion of the investigator
* Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
1 Month
ALL
Yes
Sponsors
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Masimo Corporation
INDUSTRY
Responsible Party
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Locations
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Masimo Clinical Laboratory
Irvine, California, United States
Site 1
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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TP-18216
Identifier Type: -
Identifier Source: org_study_id
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