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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test subjects | Experimental | All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rad-67 Pulse oximeter & DCI Mini sensor | Device | Noninvasive pulse oximeter that measures hemoglobin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood Bank - Site 1 | San Diego | California | 92102 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Subjects | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rad-67 Sensitivity | Sensitivity of the the Rad-67 will be determined for its use in a blood donation center | 2 subjects were excluded from analysis due to wrong device setting | Posted | Number | percentage of sensitivity | Up to one hour per subject |
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Up to one hour per subject
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vikram Ramakanth | Masimo Corporation | 949-297-7000 | clincalresearchdept@masimo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2021 | Jul 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Rad-67 Specificity | Specificity of the the Rad-67 will be determined for its use in a blood donation center | 2 subjects were excluded from analysis due to wrong device setting | Posted | Number | percentage of specificity | Up to one hour per subject |
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