Noninvasive Hemoglobin Testing, Prospective Blood Donors

Healthy Clinical Trial

Official title:

Noninvasive Hemoglobin Testing in Prospective Blood Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450381
• Other study ID #: SDBB0004
• Status: Completed
• Phase: N/A
• Start date: June 23, 2020
• Est. completion date: July 7, 2020

Study information

• Verified date: July 2021
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Blood Bank - Site 1	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rad-67 Sensitivity	Sensitivity of the the Rad-67 will be determined for its use in a blood donation center	Up to one hour per subject
Primary	Rad-67 Specificity	Specificity of the the Rad-67 will be determined for its use in a blood donation center	Up to one hour per subject