NCT06739174 Assessment of Colostomy Bags With an Active Chamber Filter System and Incidence of Filter-Related Complication
| NCT ID | NCT06739174 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Salts Healthcare |
| Condition | Colostomy - Stoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2024-11-29 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 27 participants in total. It began in 2024-11-29 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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
Contact & Investigator
Mireille Hamson
PRINCIPAL INVESTIGATOR
Salt Healthcare
Frequently Asked Questions
Who can join the NCT06739174 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colostomy - Stoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06739174 currently recruiting?
Yes, NCT06739174 is actively recruiting participants. Contact the research team at info@cssinstitute.co.uk for enrollment information.
Where is the NCT06739174 trial being conducted?
This trial is being conducted at Birmingham, United Kingdom.
Who is sponsoring the NCT06739174 clinical trial?
NCT06739174 is sponsored by Salts Healthcare. The principal investigator is Mireille Hamson at Salt Healthcare. The trial plans to enroll 27 participants.