Wetness Sensing System

Evaluation of a Wetness Sensing System for Continence Care

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 Overview

• Status: Completed
• Conditions: System Validation
• Intervention / Treatment: Device: Wetness Sensing System Validation

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

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All; 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensor Detection	Evaluate the FitRight System sensor's ability to detect when an adult brief has absorbed enough liquid (~90-360mL) normal saline via a simulated urinary void to trigger an alert to change the brief in the sitting, supine, and right or left side positions.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rewet Test	Determine the FitRight Brief's residual volume capacity. In a subset of 22 participants, evaluate the FitRight Brief after the brief has absorbed the maximum amount of liquid normal saline via a simulated urinary void (360mL) in the sitting position and then weighed via the rewet procedure.	10 minutes after the 360 milliliters saline is poured into the brief.

Collaborators and Investigators

• Sponsor: Medline Industries
• Collaborators: Rochester Clinical Research, Inc.
• Investigators: Study Director: Julie Miller, Medline Industries

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): June 29, 2022
• Study Completion (Actual): June 29, 2022

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MED-2021-DIV82-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No