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
This study is designed to evaluate the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation. One investigational sensor (INVSENSOR00038) will be placed on the somatic site of the volunteer. The values obtained by the test sensor will be compared to the reference value obtained from an FDA-cleared sensor placed on the somatic site on the contralateral side. Data will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's oxygen saturation is approximately 70%. The subject will then be returned to inhaling room air.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVSENSOR00038 | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00038 sensor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00038 | Device | Noninvasive regional oximeter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trending Accuracy of INVSENSOR00038 | This study will evaluate the trending accuracy of the INVSENSOR00038 relative to the reference value obtained from the comparative FDA-cleared device. | 1-5 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 | INVSENSOR00038 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00038 sensor. INVSENSOR00038: Noninvasive regional oximeter |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | INVSENSOR00038 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00038 sensor. INVSENSOR00038: Noninvasive regional oximeter |
| 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 | Trending Accuracy of INVSENSOR00038 | This study will evaluate the trending accuracy of the INVSENSOR00038 relative to the reference value obtained from the comparative FDA-cleared device. | Posted | Number | percentage of regional oxygen saturation | 1-5 hours |
|
|
1 to 5 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 | INVSENSOR00038 | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00038 sensor. INVSENSOR00038: Noninvasive regional oximeter |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Masimo | (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 | Jun 9, 2020 | Sep 25, 2020 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
Not provided
Not provided
Not provided