NCT05454813

Wetness Sensing System

Evaluation of a Wetness Sensing System for Continence Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Medline Industries · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• System Validation

Interventions

Type	Name	Description
DEVICE	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).

Timeline

• Start date: 2022-06-08
• Primary completion: 2022-06-29
• Completion: 2022-06-29
• First posted: 2022-07-12
• Last updated: 2023-10-03
• Results posted: 2023-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study