Status:
ENROLLING_BY_INVITATION
Stomasense: A New Route to the Proactive Detection and Management of Leaks Within Ostomy Pouches
Lead Sponsor:
University of Ulster
Conditions:
Ileostomy - Stoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
People living with an ileostomy may often experience leaks from their stoma pouches. Leakages are a highly stressful experience, so it is no surprise that worry about leaks is very common among ileost...
Detailed Description
Surgical diversion of the bowel to create an opening in the abdomen (stoma) is a common procedure in the treatment of various gastrointestinal conditions; 21 000 stomas are created in the UK each year...
Eligibility Criteria
Inclusion
- Living with an ileostomy
- ≥1.5-years post-operative
- Aged 18+ years
- Experiencing frequent leaks (i.e., more than once per week)
- Males and females (not currently pregnant/lactating)
- Self-manging their own stoma
- Access to computer / mobile device for survey completion
- No learning or other disabilities
- Have never used / trialled other leak detection systems
Exclusion
- Never had an ileostomy,
- Individuals with previous ileostomy or ostomy (colostomy or urostomy)
- \<1.5-year post-operative
- \<18 years
- Do not experience frequent leaks (i.e., less than once per week)
- Adults with learning or other disabilities
- Have previously used other leak detection systems
- Pregnant/lactating female
Key Trial Info
Start Date :
April 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06914804
Start Date
April 14 2025
End Date
January 31 2026
Last Update
April 6 2025
Active Locations (1)
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1
Ulster University, Human Intervention Studies Unit
Coleraine, Co. Derry, United Kingdom, BT521SA