Evaluation of an Ostomy Leakage Detection System

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 SkinTool (OST) 2.0 (decision tree (DT)=1 or DT=2).

6. Has experienced a leak underneath or outside the perimeter of the barrier in thelast 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 productfor duration of study

8. Currently has an Android Smart phone or an Apple iPhone of the following operatingsystems (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 informedconsent

11. Is able to receive, read, and respond to English surveys electronically (i.e. via acomputer or smart phone)

Exclusion Criteria:

1. Subject reports changing their ostomy barrier 3 or more times per day in the last 30days

2. Has an electrical implant (e.g. pacemaker or internal defibrillator) and/or bodyworn medical device (e.g. insulin pump)

3. Subject reports that a caregiver, or someone other than themselves, is solelyresponsible for changing their ostomy pouching system. Note: subjects that use acombination 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 reportsa 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 aftereligibility.

10. Is currently involved in another research study involving use of ostomy studyproducts or accessories

11. Is currently an employee of a Company that manufactures Ostomy Products and/orOstomy Accessories