Ileostomy - StomaNCT02064231
A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.
A study testing Coloplast Test A, Coloplast Test B and Own product in people with Ileostomy - Stoma, run by Coloplast A/S.
Trial summary
To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- Coloplast Test A, Coloplast Test B and Own product
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Had given written informed consent
- Was at least 18 years of age
- Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse)
- Had an ileostomy with a diameter between 15-45 mm
- Have had an ileostomy for at least 3 months
- Currently used a 2-piece flat appliance
Who cannot join
- Used irrigation during the investigation (flush stoma with water)
- Currently received or had within the past 2 months received radio- and/or chemotherapy.
- Currently received or had within the past month received local or systemic steroid treatment in the peristomal area.
- Was pregnant or breast feeding
- Participated in other interventional studies that could interfere with this one or had previously participated in this investigation.
- Had a baseplate wear time of more than three days
- Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)
About this study
To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.
- Conditions
- Ileostomy - Stoma
- Being tested
- Coloplast Test A, Coloplast Test B, Own product, Coloplast Test C, Coloplast Test D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast Test ADevice
Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
Coloplast Test BDevice
Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S
Own productDevice
Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
Coloplast Test CDevice
Coloplast Test C is a new ostomy appliance developed by Coloplast A/S
Coloplast Test DDevice
Coloplast Test D is a new ostomy appliance developed by Coloplast A/S
| Study group | Role | What they receive |
|---|---|---|
| Coloplast Test A, Coloplast Test B, Own product | Experimental | The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days Receives: Device: Coloplast Test A; Device: Coloplast Test B; Device: Own product |
| Coloplast Test C , Coloplast Test D, Own product | Experimental | The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days Receives: Device: Own product; Device: Coloplast Test C; Device: Coloplast Test D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Leakage
Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ileostomy - 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Birte p Jakobsen, MD, Principal investigator, Medical director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064231
- Sponsor's protocol ID
- CP222
- Status last verified
- Aug 2020
- First submitted
- 13 Feb 2014
- Last updated
- 10 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.
- ClinicalTrials.gov ID
- NCT02064231
- Acronym / sponsor ID
- CP222
- Conditions
- Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Posted 4 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coloplast Test A, Coloplast Test B, Own product | Experimental | Device: Coloplast Test A, Device: Coloplast Test B, Device: Own productThe subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days |
| Coloplast Test C , Coloplast Test D, Own product | Experimental | Device: Own product, Device: Coloplast Test C, Device: Coloplast Test DThe subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Had given written informed consent
- Was at least 18 years of age
- Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse)
- Had an ileostomy with a diameter between 15-45 mm
- Have had an ileostomy for at least 3 months
Key exclusion criteria (7 listed)
- Used irrigation during the investigation (flush stoma with water)
- Currently received or had within the past 2 months received radio- and/or chemotherapy.
- Currently received or had within the past month received local or systemic steroid treatment in the peristomal area.
- Was pregnant or breast feeding
- Participated in other interventional studies that could interfere with this one or had previously participated in this investigation.
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 |
|---|---|---|
| Coloplast Test AColoplast Test A is a new ostomy appliance developed by Coloplast A/S | Device | Coloplast Test A, Coloplast Test B, Own product |
| Coloplast Test BColoplast Test B is a newly developed ostomy appliance developed by Coloplast A/S | Device | Coloplast Test A, Coloplast Test B, Own product |
| Own productOwn product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others. | Device | Coloplast Test A, Coloplast Test B, Own product, Coloplast Test C , Coloplast Test D, Own product |
| Coloplast Test CColoplast Test C is a new ostomy appliance developed by Coloplast A/S | Device | Coloplast Test C , Coloplast Test D, Own product |
| Coloplast Test DColoplast Test D is a new ostomy appliance developed by Coloplast A/S | Device | Coloplast Test C , Coloplast Test D, Own product |
Primary outcome
Degree of Leakage
Time frame: 14 days
Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Birte p Jakobsen, MD principal investigator
Medical director
Questions about this trial
What is this clinical trial studying?
A study testing Coloplast Test A, Coloplast Test B and Own product in people with Ileostomy - Stoma, run by Coloplast A/S.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 4 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Leakage (time frame: 14 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 10 Sep 2020.