Status:
COMPLETED
Noninvasive Hemoglobin Repeatability and Reproducibility in a Blood Donation Setting
Lead Sponsor:
Masimo Corporation
Conditions:
Healthy
Anemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this clinical investigation is to report on the repeatability and reproducibility of SpHb measurements from Rad-67 devices and DCI Mini sensors used to screen prospective bloo...
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 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 or 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
- 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.
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04490863
Start Date
July 16 2020
End Date
August 20 2020
Last Update
August 31 2021
Active Locations (1)
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1
Blood Bank - Site 1
San Diego, California, United States, 92102