Status:
COMPLETED
Noninvasive Hemoglobin Testing, Prospective Blood Donors
Lead Sponsor:
Masimo Corporation
Conditions:
Healthy
Anemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this clinical investigation is to evaluate the pulse oximeter devices for screening prospective blood donors. The purpose study is to report on the accuracy of noninvasive hemoglobin ...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Weight at least 110 pounds
- Subjects with the intention of being screened for eligibility to donate blood
- The subject has given written informed consent to participate in the study
Exclusion
- 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, infections, abnormalities, etc.
- Subjects unwilling and/or unable to remove nail polish or acrylic nails
- Subjects with blood cancers such as leukemia
- Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia
- Subjects with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc.
- Subjects with self-disclosed/known pregnancy at the time of enrollment
- Subjects deemed not suitable for the study at the discretion of the investigator
- Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2020
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT04450381
Start Date
June 23 2020
End Date
July 7 2020
Last Update
July 27 2021
Active Locations (1)
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1
Blood Bank - Site 1
San Diego, California, United States, 92102