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Wetness Sensing System

NCT05454813 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-10-03

Study results available
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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.

Conditions

  • System Validation

Interventions

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).

Sponsors & Collaborators

  • Rochester Clinical Research

    collaborator INDUSTRY

  • Medline Industries

    lead INDUSTRY

Principal Investigators

  • Julie Miller · Medline Industries

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2022-06-29
Completion
2022-06-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05454813 on ClinicalTrials.gov