Colostomy - StomaBREEZE-01NCT06739174
Assessment of Colostomy Bags With an Active Chamber Filter System and Incidence of Filter-Related Complication
A study testing Confidence Be 1-Piece Closed Bag, Confidence Natural 1-Piece Closed Bag and Confidence Be go 1-Piece Closed Bag in people with Colostomy - Stoma and Colostomy Complications, run by Salts Healthcare at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colostomy - Stoma, Colostomy Complications
- What is being tested?
- Confidence Be 1-Piece Closed Bag, Confidence Natural 1-Piece Closed Bag and Confidence Be go 1-Piece Closed Bag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Nov 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Research contact
United Kingdom1 site, 1 recruiting
- Recruiting
Central Skin Sciences Institute (CSSI) Salts Healthcare
Birmingham, England, B7 4AA
Mireille Hamson
About this study
Official title: 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
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
Read the 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
- Being tested
- Confidence Be 1-Piece Closed Bag, Confidence Natural 1-Piece Closed Bag, Confidence Be go 1-Piece Closed Bag
- Keywords
- Colostomy bags, Colostomy, Ballooning, Pancaking, Colostomy bag filter-related complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confidence Be 1-Piece Closed BagDevice
Active Chamber Filter - Circle Shape
Confidence Natural 1-Piece Closed BagDevice
Protective Filter - Circle Shape
Confidence Be go 1-Piece Closed BagDevice
Active Chamber Filter - Hexagon Shape
| Study group | Role | What they receive |
|---|---|---|
| Confidence Be 1-Piece Closed Bag | Active comparator | The reference device is CE Marked and already commercially available Receives: Device: Confidence Be 1-Piece Closed Bag |
| Confidence Natural 1-Piece Closed Bag | Active comparator | The reference device is CE Marked and already commercially available Receives: Device: Confidence Natural 1-Piece Closed Bag |
| Confidence Be go 1-Piece Closed Bag | Active comparator | The reference device is CE Marked and already commercially available in Australia Receives: Device: Confidence Be go 1-Piece Closed Bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ballooning
Evaluation and comparison of the incidence of ballooning in colostomy bags with active chamber filter system and a protective filter
Measured: 21-days
Secondary outcomes (7)
Time of ballooning incidence
Evaluation and comparison of the timing of ballooning over a 24-hour period in colostomy bags with an active chamber filter system and a protective filter
Measured: 21-days
Wear time until ballooning incidence
Evaluation and comparison of the wear time duration of colostomy bags with an active chamber filter system and a protective filter until a ballooning incident occurs
Measured: 21-days
Incidence of pancaking
Evaluation and comparison of the incidence of pancaking in colostomy bags with an active chamber filter system and a protective filter
Measured: 21-days
Time of pancaking incidence
Evaluation and comparison of the timing of pancaking incidents over a 24-hour period in colostomy bags with an active chamber filter system and a protective filter
Measured: 21-days
Wear time until pancaking incidence
Evaluation and comparison of the wear time duration of colostomy bags with active chamber filter system and a protective filter until pancaking incident to occur
Measured: 21-days
Faecal leakage occurrence through the filter
Evaluation and comparison of faecal leakage occurrence through the filter in colostomy bags with an active chamber filter system and a protective filter
Measured: 21-days
Occurrence of odour through the filter
Evaluation and comparison of odour occurrence through the filter in colostomy bags with an active chamber filter system and a protective filter
Measured: 21-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start29 Nov 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colostomy - StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salts Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mireille Hamson, Principal investigator, Salt Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739174
- Sponsor's protocol ID
- 24/EE/0241
- Acronym
- BREEZE-01
- Status last verified
- Apr 2026
- First submitted
- 9 Dec 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06739174
- Acronym / sponsor ID
- BREEZE-01 / 24/EE/0241
- Conditions
- Colostomy - Stoma, Colostomy Complications
- Keywords
- Colostomy bags, Colostomy, Ballooning, Pancaking, Colostomy bag filter-related complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Salts HealthcareIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Confidence Be 1-Piece Closed Bag | Active comparator | Device: Confidence Be 1-Piece Closed BagThe reference device is CE Marked and already commercially available |
| Confidence Natural 1-Piece Closed Bag | Active comparator | Device: Confidence Natural 1-Piece Closed BagThe reference device is CE Marked and already commercially available |
| Confidence Be go 1-Piece Closed Bag | Active comparator | Device: Confidence Be go 1-Piece Closed BagThe reference device is CE Marked and already commercially available in Australia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Confidence Be 1-Piece Closed BagActive Chamber Filter - Circle Shape | Device | Confidence Be 1-Piece Closed Bag |
| Confidence Natural 1-Piece Closed BagProtective Filter - Circle Shape | Device | Confidence Natural 1-Piece Closed Bag |
| Confidence Be go 1-Piece Closed BagActive Chamber Filter - Hexagon Shape | Device | Confidence Be go 1-Piece Closed Bag |
Primary outcome
Incidence of ballooning
Time frame: 21-days
Evaluation and comparison of the incidence of ballooning in colostomy bags with active chamber filter system and a protective filter
7 secondary outcomes
Time of ballooning incidence
Time frame: 21-days
Wear time until ballooning incidence
Time frame: 21-days
Incidence of pancaking
Time frame: 21-days
Time of pancaking incidence
Time frame: 21-days
Wear time until pancaking incidence
Time frame: 21-days
Faecal leakage occurrence through the filter
Time frame: 21-days
Occurrence of odour through the filter
Time frame: 21-days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Research contact
Mireille Hamson principal investigator
Salt Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confidence Be 1-Piece Closed Bag, Confidence Natural 1-Piece Closed Bag and Confidence Be go 1-Piece Closed Bag in people with Colostomy - Stoma and Colostomy Complications, run by Salts Healthcare at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Jarvis Clinical Research Coordinator (+44 (0) 121 333 2015, info@cssinstitute.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ballooning (time frame: 21-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.