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The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.
The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test subjects | Experimental | All subjects are enrolled and receive Rad-67 Pulse oximeter sensor for measurement of hemoglobin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rad-67 Pulse oximeter | Device | Noninvasive pulse oximeter that measures hemoglobin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of hemoglobin measurement | Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. | Up to 2 hours per subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 4 | Burbank | California | United States | |||
| Site 5 |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
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| Burbank |
| California |
| United States |
| Site 2 | Irvine | California | United States |
| Site 7 | Lake Forest | California | United States |
| Site 3 | National City | California | United States |
| Site 6 | Torrance | California | United States |
| Site 1 | Charlotte | North Carolina | United States |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |