Noninvasive Hemoglobin Testing, Prospective Blood Donors

Not Applicable

Completed

• Conditions: Healthy; Anemia
• Interventions: Device: Rad-67 Pulse oximeter & DCI Mini sensor

• Registration Number: NCT04450381
• Lead Sponsor: Masimo Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-23
• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-29
• Primary Completion: 2020-07-07
• Study Completion: 2020-07-07
• Status Verified: 2021-07
• Results First Submitted: 2021-07-06
• Results First Submitted QC: 2021-07-06
• Last Update Submitted: 2021-07-06
• Results First Posted: 2021-07-27
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test subjects	Rad-67 Pulse oximeter & DCI Mini sensor	All subjects are enrolled and receive Rad-67 Pulse oximeter \& DCI Mini sensor for measurement of hemoglobin.

Primary Outcome Measures

Name	Time	Method
Rad-67 Sensitivity	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	Up to one hour per subject	Specificity of the the Rad-67 will be determined for its use in a blood donation center

Trial Locations

Locations (1)

Blood Bank - Site 1; 🇺🇸 San Diego, California, United States