N/A
Completed N=56
Wetness Sensing System
System Validation
Source: ClinicalTrials.gov NCT05454813 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Sensor Detection — 96.15 percentage of passes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensor Detection |
96.15 | — |
| SECONDARY Rewet Test |
18.73 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05454813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.