Noninvasive Hemoglobin Testing in Prospective Blood Donors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Masimo Corporation
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- Rad-67 Sensitivity
Study Overview
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 (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer in a blood donation setting.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Test subjects
All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin.
Intervention: Rad-67 Pulse oximeter & DCI Mini sensor (Device)
Outcomes
Primary Outcomes
Rad-67 Sensitivity
Time Frame: Up to one hour per subject
Sensitivity of the the Rad-67 will be determined for its use in a blood donation center
Rad-67 Specificity
Time Frame: Up to one hour per subject
Specificity of the the Rad-67 will be determined for its use in a blood donation center
Secondary Outcomes
No secondary outcomes reported