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Sponsor's Decision
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This Clinical Trial will evaluate the Feasibility and Acceptability of Oxygen Saturation Monitoring using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masimo SafetyNet Alert (MSNA) | Experimental | All subjects who are enrolled into the test group (excluding staff participants) and participate in data collection receive the noninvasive Masimo SafetyNet Alert (MSNA) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo SafetyNet Alert (MSNA) | Device | This study will explore the feasibility of implementing the Masimo SafetyNet Alert (MSNA) oxygen saturation monitoring system and the acceptance of MSNA by individuals living in a supportive housing program, who inject opioids. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program | Number of participants who demonstrated feasibility of MSNA in a supportive housing program | 2-4 weeks |
| Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program | Summarizing proportion of incomplete studies to evaluate the feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program. | 2-4 weeks |
| Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program | Summarizing proportion of lost components to evaluate the feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program. | 2-4 weeks |
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Inclusion Criteria for Client Participants:
Inclusion Criteria for Staff Participants:
Exclusion Criteria for Client Participants:
Exclusion Criteria for Staff Participants:
-None
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Vanier | Canada |
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No staff participants were enrolled in this study prior to termination.
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| ID | Title | Description |
|---|---|---|
| FG000 | Masimo SafetyNet Alert (MSNA) | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo SafetyNet Alert (MSNA) Masimo SafetyNet Alert (MSNA): This study will explore the feasibility of implementing the Masimo SafetyNet Alert (MSNA) oxygen saturation monitoring system and the acceptance of MSNA by individuals living in a supportive housing program, who inject opioids. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Masimo SafetyNet Alert (MSNA) | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo SafetyNet Alert (MSNA) Masimo SafetyNet Alert (MSNA): This study will explore the feasibility of implementing the Masimo SafetyNet Alert (MSNA) oxygen saturation monitoring system and the acceptance of MSNA by individuals living in a supportive housing program, who inject opioids. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program | Number of participants who demonstrated feasibility of MSNA in a supportive housing program | 4 out of the 10 subjects were not completed due to physician decision, withdrawal by subject, or by death (unrelated to device, subject never participated in any study activities) | Posted | Number | participants | 2-4 weeks |
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Entirety of study (60 days)
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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 SafetyNet Alert (MSNA) | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo SafetyNet Alert (MSNA) Masimo SafetyNet Alert (MSNA): This study will explore the feasibility of implementing the Masimo SafetyNet Alert (MSNA) oxygen saturation monitoring system and the acceptance of MSNA by individuals living in a supportive housing program, who inject opioids. |
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Early termination leading to small numbers of subjects analyzed. Some outcome measures could not be calculated due to small number of subjects being analyzed. No staff participants were enrolled in this study prior to termination.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Masimo | 949-297-7000 | clinicalresearchdept@masimo.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 14, 2023 | Apr 7, 2025 | Prot_001.pdf |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Primary | Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program | Summarizing proportion of incomplete studies to evaluate the feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program. | Posted | Number | incomplete studies | 2-4 weeks |
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| Primary | Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program | Summarizing proportion of lost components to evaluate the feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program. | Posted | Number | lost components | 2-4 weeks |
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| 1 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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