Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related… (NCT06739174) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication
United Kingdom27 participantsStarted 2024-11-29
Plain-language summary
This 3-way crossover study aims to evaluate whether colostomy bags with an active chamber filter system reduce the incidence of filter-related complications, such as ballooning and pancaking, help neutralise odour, and minimise faecal leakage through the filter compared to colostomy bags with a protective filter
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult aged over 18 years
* Colostomy for 6 months or longer
* Experiences any filter-related complications, such as ballooning, pancaking, odour, or faecal leakage through the filter, at least once a week (7 days)
* Independent in colostomy care
* Using a flat, closed colostomy bag
* Stoma size (diameter) less than 55 mm
* Using a colostomy bag with a hydrocolloid wafer (baseplate)
* Able to read and complete the study questionnaire in English
Exclusion Criteria:
* Uses colostomy irrigation
* Bleeding or broken peristomal skin
* Receiving or had radiotherapy or chemotherapy in the last 2 months
* Pregnant or breastfeeding
* Taking part in another clinical study
* Currently receiving treatment under the care of a stoma clinical nurse specialist
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.