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

NCT ID: NCT06739174

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-29

Study Completion Date

2025-04-30

Brief Summary

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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

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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

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Colostomy - Stoma Colostomy Complications

Keywords

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Colostomy bags Colostomy Ballooning Pancaking Colostomy bag filter-related complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Confidence Be 1-Piece Closed Bag

The reference device is CE Marked and already commercially available

Group Type ACTIVE_COMPARATOR

Confidence Be 1-Piece Closed Bag

Intervention Type DEVICE

Active Chamber Filter - Circle Shape

Confidence Natural 1-Piece Closed Bag

The reference device is CE Marked and already commercially available

Group Type ACTIVE_COMPARATOR

Confidence Natural 1-Piece Closed Bag

Intervention Type DEVICE

Protective Filter - Circle Shape

Confidence Be go 1-Piece Closed Bag

The reference device is CE Marked and already commercially available in Australia

Group Type ACTIVE_COMPARATOR

Confidence Be go 1-Piece Closed Bag

Intervention Type DEVICE

Active Chamber Filter - Hexagon Shape

Interventions

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Confidence Be 1-Piece Closed Bag

Active Chamber Filter - Circle Shape

Intervention Type DEVICE

Confidence Natural 1-Piece Closed Bag

Protective Filter - Circle Shape

Intervention Type DEVICE

Confidence Be go 1-Piece Closed Bag

Active Chamber Filter - Hexagon Shape

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Salts Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mireille Hamson

Role: PRINCIPAL_INVESTIGATOR

Salt Healthcare

Locations

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Central Skin Sciences Institute (CSSI) Salts Healthcare

Birmingham, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Clinical Research Coordinator

Role: CONTACT

Phone: +44 (0) 121 333 2015

Email: [email protected]

Clinical Research Nurse

Role: CONTACT

Phone: 07917630767

Email: [email protected]

Facility Contacts

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Mireille Hamson

Role: primary

Other Identifiers

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24/EE/0241

Identifier Type: -

Identifier Source: org_study_id