Noninvasive Hemoglobin Testing, Prospective Blood Donors

Overview

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.

Full Title of Study: “Noninvasive Hemoglobin Testing in Prospective Blood Donors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 7, 2020

Interventions

  • Device: Rad-67 Pulse oximeter & DCI Mini sensor
    • Noninvasive pulse oximeter that measures hemoglobin

Arms, Groups and Cohorts

  • Experimental: Test subjects
    • All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin.

Clinical Trial Outcome Measures

Primary Measures

  • Rad-67 sensitivity and specificity
    • Time Frame: Up to one hour per subject
    • Sensitivity and specificity of the the Rad-67 will be determined for its use in a blood donation center

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Masimo Corporation
  • Provider of Information About this Clinical Study
    • Sponsor

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