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The primary objective of this clinical investigation is to report on the repeatability and reproducibility of SpHb measurements from Rad-67 devices and DCI Mini sensors used to screen prospective blood donors at a donation center.
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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 |
|---|---|---|
| Coefficient of Variation of Rad-67 | Coefficient of variation will be computed using Repeatability and Reproducibility variance. | Approximately 90 minutes 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 Rad-67 Pulse oximeter & DCI Mini 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 |
|
| 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 | Coefficient of Variation of Rad-67 | Coefficient of variation will be computed using Repeatability and Reproducibility variance. | Posted | Number | Coefficient of Variation percentage | Approximately 90 minutes per subject |
|
|
Approximately 90 minutes 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 Rad-67 Pulse oximeter & DCI Mini 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 | ClinicalResearchDept@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 24, 2020 | 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 |
|
| 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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| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
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