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This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masimo Centroid System | Experimental | Single-arm study. All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo Centroid System | Device | Noninvasive positional monitoring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Usability Validation of Masimo Centroid System | The number of participants enrolled to assess the usability of the Masimo Centroid System. | At least 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Masimo Centroid System | All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Masimo Centroid System | All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered. |
| 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 | Usability Validation of Masimo Centroid System | The number of participants enrolled to assess the usability of the Masimo Centroid System. | Posted | Count of Participants | Participants | At least 8 hours |
|
|
at least 8 hours and up to 16 hours of enrollment.
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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 | Masimo Centroid System | All subjects are enrolled into the test group wherein the noninvasive positional monitoring device will be administered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vikram Ramakanth | Masimo Corporation | (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 | Dec 17, 2018 | May 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
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