Clinical trial NCT05454813: Wetness Sensing System
Official title: Evaluation of a Wetness Sensing System for Continence Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: System Validation
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
Collaborators: name: Rochester Clinical Research
First posted: 2022-07-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Sensor Detection
timeFrame: 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).
Secondary outcomes:
measure: Rewet Test
timeFrame: 10 minutes after the 360 milliliters saline is poured into the brief.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
Study officials:
affiliation: Medline Industries
name: Julie Miller
role: STUDY_DIRECTOR
References: