Trial Outcomes & Findings for Noninvasive Hemoglobin Testing, Prospective Blood Donors (NCT NCT04450381)

NCT ID: NCT04450381

Last Updated: 2021-07-27

Results Overview

Sensitivity of the the Rad-67 will be determined for its use in a blood donation center

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 131 participants
• Primary outcome timeframe: Up to one hour per subject
• Results posted on: 2021-07-27

Participant Flow

Participant milestones

Measure	Test Subjects 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
Overall Study STARTED	131
Overall Study COMPLETED	125
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Test Subjects 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
Overall Study Protocol Violation	4
Overall Study Wrong device setting	2

Baseline Characteristics

Noninvasive Hemoglobin Testing, Prospective Blood Donors

Baseline characteristics by cohort

Measure	Test Subjects n=125 Participants 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
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	106 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	16 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	76 Participants n=5 Participants
Race/Ethnicity, Customized Race · More Than One Race	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown or Not Reported	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other: American	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other: Assyrian	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other: Mexican	16 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other: Native American	1 Participants n=5 Participants
Region of Enrollment United States	125 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to one hour per subject

Population: 2 subjects were excluded from analysis due to wrong device setting

Sensitivity of the the Rad-67 will be determined for its use in a blood donation center

Outcome measures

Measure	Test Subjects n=123 Participants 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
Rad-67 Sensitivity	44 percentage of sensitivity

PRIMARY outcome

Timeframe: Up to one hour per subject

Population: 2 subjects were excluded from analysis due to wrong device setting

Specificity of the the Rad-67 will be determined for its use in a blood donation center

Outcome measures

Measure	Test Subjects n=123 Participants 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
Rad-67 Specificity	86.73 percentage of specificity

Adverse Events

Test Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vikram Ramakanth

Masimo Corporation

Phone: 949-297-7000

Email: clincalresearchdept@masimo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60