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New treatment option for Colostomy - Stoma
Official title Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication
ClinicalTrials.gov ID: NCT06739174
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Independent in colostomy care
- Using a flat, closed colostomy bag
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, England, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, England, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.