Evaluation of an Ostomy Leakage Detection System

Hollister Incorporated22 enrolled

Overview

This study will evaluate the safety and efficacy of an ostomy leakage detection system.

Individuals with an ostomy will be recruited to evaluate an ostomy leakage detection system. The ostomy leakage detection system is designed to detect leaks and notify users of the leaks. Participants will evaluate the safety and efficacy of the leakage detection system.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Ostomy

Interventions

Ostomy Leakage Detection SystemDEVICE

A system that is used to detect ostomy leaks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18 years or Older 2. Currently resides in the United Kingdom 3. Has an ileostomy, colostomy, or urostomy 4. Has a stoma diameter within the following range: 15 mm - 70 mm 5. Has a mild or moderate peristomal skin complication as defined using the Ostomy Skin Tool (OST) 2.0 (decision tree (DT)=1 or DT=2). 6. Has experienced a leak underneath or outside the perimeter of the barrier in the last 30 days or has worried about leakage in the last 30 days 7. Willing to use their typical ostomy pouching system together with the study product for duration of study 8. Currently has an Android Smart phone or an Apple iPhone of the following operating systems (OS): * a. Android Devices: * i. Compatible Brands: Samsung Galaxy, Huawei, Google Pixel * ii. Operating System: Android OS 9.0 (Pie) and later * b. Apple iPhones: * i. Compatible Models: iPhone X and later * ii. Operating System: iPhone Operating System (iOS) 15 and newer 9. Is willing to download the phone application for use during the study 10. Is willing to follow protocol procedures, as indicated by signing the informed consent 11. Is able to receive, read, and respond to English surveys electronically (i.e. via a computer or smart phone) Exclusion Criteria: 1. Subject reports changing their ostomy barrier 3 or more times per day in the last 30 days 2. Has an electrical implant (e.g. pacemaker or internal defibrillator) and/or body worn medical device (e.g. insulin pump) 3. Subject reports that a caregiver, or someone other than themselves, is solely responsible for changing their ostomy pouching system. Note: subjects that use a combination of self-care and other assistance should not be excluded. 4. Reports as legally blind and/or deaf 5. Subject does not report a peristomal skin complication (PSC) or the subject reports a PSC that is scored as severe on the OST 2.0 tool (either a DT=0 or DT=3). 6. Subject reports currently having an abdominal fistula or abdominal wound 7. Subject has more than one stoma 8. Is undergoing chemotherapy, radiation, or non-inhaled steroid therapy (topical/applied to the skin around the stoma) that may compromise the skin 9. Is pregnant or breastfeeding at time of eligibility, as determined by self-report. Note: this exclusion will not be re-confirmed throughout the study after eligibility. 10. Is currently involved in another research study involving use of ostomy study products or accessories 11. Is currently an employee of a Company that manufactures Ostomy Products and/or Ostomy Accessories

Locations (1)

PPD Development, L.P.; Decentralized, Virtual Site; 11 Granta Park

Cambridge, Cambridgeshire, United Kingdom

Outcomes

Primary Outcomes

The Accuracy of the Leakage Detection System (LDS)

The frequency of true positive, true negative, false positive, and false negative leakage detection events will be used to quantify the accuracy of the leakage detection system.