Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT06914804
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06914804
Study Brief:
Protocol Section:
NCT06914804