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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
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Volunteers
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:
b. Apple iPhones:
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
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Central trial contact
Mackenzie Juckett
Data sourced from clinicaltrials.gov
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