Evaluation of an Ostomy Leakage Detection System

Hollister

Status: Enrolling

Conditions: Ostomy

Treatments: Device: Ostomy Leakage Detection System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06547905

6028-OST

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Leakage Detection System arm

Experimental group

Description:

Participants will utilize the leakage detection system

Treatment:

Device: Ostomy Leakage Detection System