Noninvasive Hemoglobin Testing, Prospective Blood Donors

• Sponsor: Masimo Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04450381
• Collaborator: (none)
• Enrollment: 131
• Location: 1
• Arm: 1
• Actual Duration (Days): 14
• Patients Per Site Per Month: 284.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Anemia	Device: Rad-67 Pulse oximeter & DCI Mini sensor	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 131 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Noninvasive Hemoglobin Testing in Prospective Blood Donors
• Actual Study Start Date: Jun 23, 2020
• Actual Primary Completion Date: Jul 7, 2020
• Actual Study Completion Date: Jul 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test subjects All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin.	Device: Rad-67 Pulse oximeter & DCI Mini sensor; Noninvasive pulse oximeter that measures hemoglobin

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Blood Bank - Site 1	San Diego	California	United States	92102

Sponsors and Collaborators

• Masimo Corporation

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 1, 2021

More Information

Publications

None provided.

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT04450381
• Other Study ID Numbers: SDBB0004
• First Posted: Jun 29, 2020
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	Test Subjects
Arm/Group Description	All subjects are enrolled and receive the Pulse oximeter & sensor for measurement of hemoglobin. Rad-67 Pulse oximeter & DCI mini sensor: Noninvasive pulse oximeter that measures hemoglobin
Period Title: Overall Study
STARTED	131
COMPLETED	125
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Test Subjects
Arm/Group Description	All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin. Rad-67 Pulse oximeter & DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin
Overall Participants	125
Age (Count of Participants)
<=18 years	1 0.8%
Between 18 and 65 years	106 84.8%
>=65 years	18 14.4%
Sex: Female, Male (Count of Participants)
Female	76 60.8%
Male	49 39.2%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	1 0.8%
Asian	16 12.8%
Native Hawaiian or Other Pacific Islander	2 1.6%
Black or African American	2 1.6%
White	76 60.8%
More Than One Race	6 4.8%
Unknown or Not Reported	3 2.4%
Other: American	1 0.8%
Other: Assyrian	1 0.8%
Other: Mexican	16 12.8%
Other: Native American	1 0.8%
Region of Enrollment (participants) [Number]
United States	125 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

2 subjects were excluded from analysis due to wrong device setting

Arm/Group Title	Test Subjects
Arm/Group Description	All subjects are enrolled and receive the Pulse oximeter & sensor for measurement of hemoglobin. Rad-67 Pulse oximeter & DCI mini sensor: Noninvasive pulse oximeter that measures hemoglobin
Measure Participants	123
Number [percentage of sensitivity]	44

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

2 subjects were excluded from analysis due to wrong device setting

Arm/Group Title	Test Subjects
Arm/Group Description	All subjects are enrolled and receive the Pulse oximeter & sensor for measurement of hemoglobin. Rad-67 Pulse oximeter & DCI mini sensor: Noninvasive pulse oximeter that measures hemoglobin
Measure Participants	123
Number [percentage of specificity]	86.73

Adverse Events

Time Frame	Up to one hour per subject
Arm/Group Title	Test Subjects
Arm/Group Description	All subjects are enrolled and receive the Pulse oximeter & sensor for measurement of hemoglobin. Rad-67 Pulse oximeter & DCI mini sensor: Noninvasive pulse oximeter that measures hemoglobin
All Cause Mortality
	Test Subjects
	Affected / at Risk (%)	# Events
Total	0/131 (0%)
Serious Adverse Events
	Test Subjects
	Affected / at Risk (%)	# Events
Total	0/131 (0%)
Other (Not Including Serious) Adverse Events
	Test Subjects
	Affected / at Risk (%)	# Events
Total	0/131 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.