The purpose of this study is to determine if the sponsor's Incontinence Product reduces
patient exposure time to a wet and/or soiled incontinence pad.
Other: Incontinence Detection System
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Full eligibility criteria for NCT03023072
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
English speaking/reading adults, age ≥ 18 years
Incontinent (fecal, urine, or dual incontinence)
Patients with dual incontinence who require use of a fecal management system (but no urinary catheter)
Absence of skin irritation, breakdown, and pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the Study Investigator
Willing and able to provide written informed consent or legal authorized representative is willing and able to provide written informed consent
Presence of skin irritation and/or breakdown including but not limited to IAD or pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the study Investigator
Require use of an absorbent undergarment (e.g. Depends) or catheter as the primary incontinence management strategy
Is considered to be near death or requires hospice care
All locations for NCT03023072
United States (1)
Parkview Regional Medical Center
Fort Wayne, Indiana, United States
View full eligibility
Tris trial is registered with FDA with number: NCT03023072. The sponsor of the trial is Hill-Rom and it is looking for 9 volunteers for the current phase.
Official trial title:
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