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Sponsor terminated study due to project timeline.
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The aim of the study is to compare the performance of the O3 cerebral oximeter and sensor to a 510(k) cleared NIRS (Near-Infrared Spectroscopy) device on neonatal subjects based on data collected from the cutaneously placed forehead sensors. Due to the design of the systems, the devices will be used serially instead of concurrently. Because of this timing, changes in patient state may not be reflected in measurements collected by both devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonatal Test group | Experimental | Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo O3 Neonatal Sensors | Device | Regional Oximetry sensor for Neonates |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With rSO2 Collected | In order to obtain the RMS value, rSO2 values collected from the control device (510(k) cleared regional oximetry sensor) is subtracted from the rSO2 values collected from the investigational device (Masimo O3 neonatal sensors) for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value. | Data collection period; alternating sensors every 5 minutes for up to 20 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neonatal Test Group | Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor. Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates 510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neonatal Test Group | Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor. Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates 510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates |
| 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 | Number of Participants With rSO2 Collected | In order to obtain the RMS value, rSO2 values collected from the control device (510(k) cleared regional oximetry sensor) is subtracted from the rSO2 values collected from the investigational device (Masimo O3 neonatal sensors) for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value. | Study was prematurely terminated. Study did not reach the target number of subjects needed to achieve minimum sample size determination and was insufficient to produce statistically reliable results. | Posted | Count of Participants | Participants | Data collection period; alternating sensors every 5 minutes for up to 20 minutes. |
|
1 day
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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 | Neonatal Test Group | Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor. Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates 510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates |
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Study did not reach the target number of subjects needed to achieve minimum sample size determination and was insufficient to produce statistically reliable results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vikram Ramakanth | Masimo Corporation | 949-297-7416 | 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 | Feb 14, 2019 | May 6, 2020 | Prot_SAP_000.pdf |
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| 510(k) cleared sensor |
| Device |
Cleared Regional Oximetry sensor for Neonates |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.
Masimo O3 Neonatal Sensors: Regional Oximetry sensor for Neonates
510(k) cleared sensor: Cleared Regional Oximetry sensor for Neonates
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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