Wetness Sensing System

Medline Industries

Status

Completed

Conditions

System Validation

Treatments

Device: Wetness Sensing System Validation

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05454813

MED-2021-DIV82-002

Details and patient eligibility

About

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.

Full 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

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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