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| Name | Class |
|---|---|
| Rochester Clinical Research | INDUSTRY |
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The investigational product to be evaluated in this study is FitRight® ConnectTM Wetness Sensing System which includes: the FitRight® ConnectTM Pod, the FitRight® ConnectTM App, the FitRight® ConnectTM charger/adapter and the FitRight® ConnectTM Sensing Brief-(Medline Industries, LP) henceforth, referred to as FitRight® System, Pod, App, Charger, Alert Indicator and Brief. The purpose of this study is to validate the FitRight System sensor's ability to detect when an adult brief has absorbed enough liquid (~90-360 milliliters (mL)) normal saline via simulated urinary void to trigger an alert to change the brief.
Each participant will be provided with the FitRight® System for the duration of the study. The study products will be used to collect real-life measurement data in order to assess the FitRight® System. Each participant will be asked to wear at least three briefs so that they are wearing each brief during the simulated voids performed by the site staff. The site staff will perform the simulated void by addition of (90-360 mL normal saline to the brief. The FitRight® System will be assessed for alerts while participants are in the following positions: supine, sitting, and laying on either left or right side. Each participant will be randomized to either the left or right side. Twenty-two of the fifty-six participants will perform rewet testing procedures. The study results will be used to assess the reliability of the device's absorption to trigger an alert
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All | Other | Each participant will be provided with the FitRight ® System for the duration of the study. The study products will be used to collect real-life measurement data in order to assess the FitRight® System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wetness Sensing System Validation | Device | Participants will use the Wetness Sensing System in a simulated setting in the sitting, supine and side position (participants are randomized to either the left or right side position). |
| Measure | Description | Time Frame |
|---|---|---|
| Sensor Detection | Evaluate the FitRight System sensor's ability to detect when an adult brief has absorbed enough liquid (~90-360mL) normal saline via a simulated urinary void to trigger an alert to change the brief in the sitting, supine, and right or left side positions. | 5 minutes after each amount (90-360 milliliters) saline is poured into the brief. There could be up to four pours for each brief and 3 briefs (one for each position). |
| Measure | Description | Time Frame |
|---|---|---|
| Rewet Test | Determine the FitRight Brief's residual volume capacity. In a subset of 22 participants, evaluate the FitRight Brief after the brief has absorbed the maximum amount of liquid normal saline via a simulated urinary void (360mL) in the sitting position and then weighed via the rewet procedure. | 10 minutes after the 360 milliliters saline is poured into the brief. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Miller | Medline Industries | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
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All participants are combined in one arm for the analysis because the first two positions are the same for all participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Each participant will be provided with the FitRight ® System for the duration of the study. The study products will be used to collect real-life measurement data in order to assess the FitRight® System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Each participant will be provided with the FitRight ® System for the duration of the study. The study products will be used to collect real-life measurement data in order to assess the FitRight® System. |
| 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 | Sensor Detection | Evaluate the FitRight System sensor's ability to detect when an adult brief has absorbed enough liquid (~90-360mL) normal saline via a simulated urinary void to trigger an alert to change the brief in the sitting, supine, and right or left side positions. | Four participants were removed from the analysis because of deviations. The measure type mean was chosen below because the unit of measure is the percentage of passes. | Posted | Mean | 95% Confidence Interval | percentage of passes | 5 minutes after each amount (90-360 milliliters) saline is poured into the brief. There could be up to four pours for each brief and 3 briefs (one for each position). |
|
2 hours
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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 | All Participants | Each participant will be provided with the FitRight ® System for the duration of the study. The study products will be used to collect real-life measurement data in order to assess the FitRight® System. Wetness Sensing System Validation: Participants will use the Wetness Sensing System in a simulated setting in the sitting, supine and side position (participants are randomized to either the left or right side position). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Miller | Medline Industries, L:P | 630-418-6891 | jamiller@medline.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 | Jun 16, 2022 | Jun 13, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2022 | Jun 13, 2023 | ICF_001.pdf |
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| Participants |
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| Sex/Gender, Customized | 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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| Region of Enrollment | Number | participants |
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| Secondary | Rewet Test | Determine the FitRight Brief's residual volume capacity. In a subset of 22 participants, evaluate the FitRight Brief after the brief has absorbed the maximum amount of liquid normal saline via a simulated urinary void (360mL) in the sitting position and then weighed via the rewet procedure. | A convenient subset of the first 22 completed participants was recruited. The unit of measure below is percent change in paper weight from dry. for the rewet procedure. | Posted | Mean | Standard Deviation | percent change | 10 minutes after the 360 milliliters saline is poured into the brief. |
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| 56 |
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| 56 |
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