System Validation
Conditions
Brief summary
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.
Detailed description
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
Interventions
DEVICEWetness 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).
Sponsors
Rochester Clinical Research
Medline Industries
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Individuals at least18 years of age * Individual can dress and undress self with no assistance * Individuals can ambulate without assistance * Individual can sit unsupported in a chair or on bedside with no assistance * Individual can lay supine and propel self up with no assistance * Individual can lie left/right lateral and propel self up with no assistance * Individuals who have hip dimensions between 32 and 70 (81-178 cm
Exclusion criteria
* Individual is sensitive to the components of the study product(s). * Individual is considered inappropriate by the Principal Investigator (PI). * Individual has self-reported current skin condition(s) or issues around the sacral or perineal areas, such as open sores, sacral pressure injuries, rash, burns, surgical wounds and/or compromise of skin integrity. * Individuals who cannot complete all phases of the study requirements. * Individual requires use of an absorbent undergarment or catheter as the primary incontinence management strategy * Individuals who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensor Detection | 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rewet Test | 10 minutes after the 360 milliliters saline is poured into the brief. | 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. |
Countries
United States
Participant flow
Pre-assignment details
All participants are combined in one arm for the analysis because the first two positions are the same for all participants.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 56 |
| Total | 56 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 37 Participants | — |
| Age, Categorical Between 18 and 65 years | 19 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 56 participants | — |
| Sex/Gender, Customized Decline to Answer | 0 Participants | — |
| Sex/Gender, Customized Female | 38 Participants | — |
| Sex/Gender, Customized Male | 18 Participants | — |
| Sex/Gender, Customized Other | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 56 |
| other Total, other adverse events | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 |
Outcome results
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.
Time frame: 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).
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Sensor Detection | 96.15 percentage of passes |
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.
Time frame: 10 minutes after the 360 milliliters saline is poured into the brief.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Rewet Test | 18.73 percent change | Standard Deviation 25.36 |