Assessment of Colostomy Bags With an Active Chamber Filter System and Incidence of Filter-Related Complication

NCT06739174 · tracked via the Priya Life Science UK tracker

Sponsor

Salts Healthcare

Phase

Not applicable

Started

2024-11-29

Last updated

2026-07-23

Condition(s) studied

Colostomy - StomaColostomy Complications

Investigational drug(s) / intervention(s)

Confidence Be 1-Piece Closed BagConfidence Natural 1-Piece Closed BagConfidence Be go 1-Piece Closed Bag

Confidence Be 1-Piece Closed Bag: Active Chamber Filter - Circle Shape

Confidence Natural 1-Piece Closed Bag: Protective Filter - Circle Shape

Confidence Be go 1-Piece Closed Bag: Active Chamber Filter - Hexagon Shape

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence of ballooning — 21-days
Evaluation and comparison of the incidence of ballooning in colostomy bags with active chamber filter system and a protective filter

Trial sites (1)

Facility	City	Region	Status
Central Skin Sciences Institute (CSSI) Salts Healthcare	Birmingham	England	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06739174 on ClinicalTrials.gov ↗ ← All trials in the UK