Evaluation of an Ostomy Leakage Detection System

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Hollister Incorporated
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Updated on 2 December 2024
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Summary

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

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.

Details
Condition Ostomy
Age 18years or above
Treatment Ostomy Leakage Detection System
Clinical Study IdentifierNCT06547905
SponsorHollister Incorporated
Last Modified on2 December 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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