NCT06739174

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

Three Way Crossover Study: Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication by People Living with a Colostomy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Salts Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study will recruit participants living with a colostomy who experience complications related to colostomy bag filters. The study follows a repeated-measures design, in which each participant will test three types of colostomy bags (A, B, and C) over a 21-day period, divided into three 7-day test periods. During each test period, participants will use one type of colostomy bag for 7-days or up to 21 closed bags. Participants will be instructed to change the colostomy bag as often as they normally would or whenever they deem it necessary

Conditions

• Colostomy - Stoma
• Colostomy Complications

Interventions

Type	Name	Description
DEVICE	Confidence Be 1-Piece Closed Bag	Active Chamber Filter - Circle Shape
DEVICE	Confidence Natural 1-Piece Closed Bag	Protective Filter - Circle Shape
DEVICE	Confidence Be go 1-Piece Closed Bag	Active Chamber Filter - Hexagon Shape

Timeline

• Start date: 2024-11-29
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2024-12-18
• Last updated: 2024-12-18

Locations

1 site across 1 country: United Kingdom