Status:
COMPLETED
Evaluation of an Ostomy Leakage Detection System
Lead Sponsor:
Hollister Incorporated
Conditions:
Ostomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate the safety and efficacy of an ostomy leakage detection system.
Detailed 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...
Eligibility Criteria
Inclusion
- 18 years or Older
- Currently resides in the United Kingdom
- Has an ileostomy, colostomy, or urostomy
- Has a stoma diameter within the following range: 15 mm - 70 mm
- 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).
- 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
- Willing to use their typical ostomy pouching system together with the study product for duration of study
- 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
- Is willing to download the phone application for use during the study
- Is willing to follow protocol procedures, as indicated by signing the informed consent
- Is able to receive, read, and respond to English surveys electronically (i.e. via a computer or smart phone)
Exclusion
- Subject reports changing their ostomy barrier 3 or more times per day in the last 30 days
- Has an electrical implant (e.g. pacemaker or internal defibrillator) and/or body worn medical device (e.g. insulin pump)
- 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.
- Reports as legally blind and/or deaf
- 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).
- Subject reports currently having an abdominal fistula or abdominal wound
- Subject has more than one stoma
- Is undergoing chemotherapy, radiation, or non-inhaled steroid therapy (topical/applied to the skin around the stoma) that may compromise the skin
- 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.
- Is currently involved in another research study involving use of ostomy study products or accessories
- Is currently an employee of a Company that manufactures Ostomy Products and/or Ostomy Accessories
Key Trial Info
Start Date :
July 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06547905
Start Date
July 24 2024
End Date
November 15 2024
Last Update
March 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PPD Development, L.P.; Decentralized, Virtual Site; 11 Granta Park
Cambridge, Cambridgeshire, United Kingdom, CB21 6GQ