CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
Wetness Sensing System Validationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05454813
NCT05454813N/ACompleted
CompareCT.gov

Evaluation of a Wetness Sensing System for Continence Care

Medline Industries·interventional·Posted Jul 12, 2022·Updated Oct 3, 2023

In Brief

A clinical study evaluating Wetness Sensing System Validation for System Validation. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystem Validation
CountriesUnited States
CollaboratorsRochester Clinical Research

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 12, 2022
Enrollment StartJun 8, 2022
Primary CompletionJun 29, 2022
TodayJul 2, 2026
Enrollment to primary: 21 daysPosted 4.0 years ago

Interventions

Wetness Sensing System Validationdevice

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).