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Sponsor Decision
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This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVSENSOR00045 | Experimental | All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00045 | Device | Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate. |
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| Measure | Description | Time Frame |
|---|---|---|
| Form, Fit and Function of INVSENSOR00045. | To observe form, fit, and function of the INVSENSOR00045 sensors in the neonatal population with convenience sampling in a clinical environment. Data collected using the sensors will be compared to the reference values (RMS). | Up to 8 hours per subject. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 2 | Orange | California | 92868 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | INVSENSOR00045 | All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital. INVSENSOR00045: Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | INVSENSOR00045 | All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital. INVSENSOR00045: Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate. |
| 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 | Form, Fit and Function of INVSENSOR00045. | To observe form, fit, and function of the INVSENSOR00045 sensors in the neonatal population with convenience sampling in a clinical environment. Data collected using the sensors will be compared to the reference values (RMS). | Data was obtained from all participants and there were no signal quality issues. The study was terminated early and the sample size was insufficient to statistically compare data collected to the reference values. Hence, the root mean square error (RMS) could not be computed. | Posted | Number | number of issues with form/fit &function | Up to 8 hours per subject. |
|
Up to 8 hours
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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 | INVSENSOR00045 | All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital. INVSENSOR00045: Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Masimo | 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 | Mar 26, 2024 | Nov 27, 2024 | Prot_SAP_000.pdf |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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