Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the form, fit, and function of INVSENSOR00061 when used on newborn and infant subjects 0-18 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Subjects | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVENSOR00061 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00061 | Device | Noninvasive pulse oximetry and pulse rate device |
|
| Measure | Description | Time Frame |
|---|---|---|
| INVSENSOR00061 SpO2 Accuracy | The SpO2 accuracy of INVSENSOR00061 was determined by calculating the accuracy root mean squared (Arms) difference between the measured values (SpO2i) to the reference values (SpO2ref_i) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2_i-SpO2ref_i )^2 ))/n | 2 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masimo Corporation | Irvine | California | 92618 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Test Subjects | All subjects who are enrolled into the test group and receive the noninvasive INVENSOR00061 INVSENSOR00061: Noninvasive pulse oximetry and pulse rate device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Test Subjects | All subjects who are enrolled into the test group and received the noninvasive INVENSOR00061. INVSENSOR00061: Noninvasive pulse oximetry and pulse rate device |
| 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 | INVSENSOR00061 SpO2 Accuracy | The SpO2 accuracy of INVSENSOR00061 was determined by calculating the accuracy root mean squared (Arms) difference between the measured values (SpO2i) to the reference values (SpO2ref_i) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2_i-SpO2ref_i )^2 ))/n | 11 subjects not included in analysis due to incorrect sensor placement. 29 subjects not included in analysis due to absence of reference sensor used to calculate Arms. | Posted | Number | % of SpO2 | 2 hours |
|
2 hours to 48 hours
Not provided
Not provided
| 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 who are enrolled into the test group and receive the noninvasive INVENSOR00061 INVSENSOR00061: Noninvasive pulse oximetry and pulse rate device |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Alghazi | Masimo Corporation | 949-297-7000 | studies@masimo.com |
Not provided
| 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 | Apr 3, 2024 | May 30, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
Not provided
Not provided
Not provided