IleostomyNCT02351817
An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products
A study testing Test A, Test B and Baseline in people with Ileostomy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The primary objective of the investigation is to explore the acceptance of a newly developed adhesive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy
- What is being tested?
- Test A, Test B and Baseline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2015to Mar 2015
- 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
- Have given written informed consent and letter of authority
- Be at least 18 years of age and have full legal capacity
- Be able to handle the products her/himself
- Have an ileostomy with a diameter between 10 and 30 mm
- Willing to follow the product change schedule (one change per day)
- Have had their ostomy for at least three months
Show all 10Show fewer
- Willing to use 1 piece open ostomy products during the test period
- Must be able to use a custom cut product
- Have intact skin
- Negative result of a pregnancy test for women of childbearing age
Who cannot join
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/ injection) treatment
- Is pregnant or breastfeeding.
- Is participating in other interventional clinical investigations or have previously participated in this investigation
- Have a loop ileostomy
- Known hypersensitivity towards any of the test products
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.
- Conditions
- Ileostomy
- Being tested
- Test A, Test B, Baseline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test ADevice
Ostomy appliance
Test BDevice
Ostomy appliance
BaselineDevice
Ostomy appliance
| Study group | Role | What they receive |
|---|---|---|
| Baseline - Test A - Test B | Experimental | Three period investigation. First each subject tests baseline product, then Test A and finally Test B.
Baseline product: the subject's usual product
Test A: A newly developed 1-piece, open ostomy appliance for collecting feces
Test B: A newly developed 1-piece, open ostomy appliance for collecting feces Receives: Device: Test A; Device: Test B; Device: Baseline |
| Baseline - Test B - Test A | Experimental | First each subject tests baseline product, then Test B and finally Test A.
Baseline product: the subject's usual product
Test A: A newly developed 1-piece, open ostomy appliance for collecting feces
Test B: A newly developed 1-piece, open ostomy appliance for collecting feces Receives: Device: Test A; Device: Test B; Device: Baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product Acceptance
Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products.
There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate.
The result presented below shows how many subjects preferred Test A/Test B over own product
Measured: 7 days per test period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionMar 2015
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 IleostomyStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Birte Petersen Jakobsen, MD, Principal investigator, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351817
- Sponsor's protocol ID
- CP256
- Status last verified
- Dec 2015
- First submitted
- 27 Jan 2015
- Last updated
- 6 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products
- ClinicalTrials.gov ID
- NCT02351817
- Acronym / sponsor ID
- CP256
- Conditions
- Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Posted 30 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline - Test A - Test B | Experimental | Device: Test A, Device: Test B, Device: BaselineThree period investigation. First each subject tests baseline product, then Test A and finally Test B. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces |
| Baseline - Test B - Test A | Experimental | Device: Test A, Device: Test B, Device: BaselineFirst each subject tests baseline product, then Test B and finally Test A. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have given written informed consent and letter of authority
- Be at least 18 years of age and have full legal capacity
- Be able to handle the products her/himself
- Have an ileostomy with a diameter between 10 and 30 mm
- Willing to follow the product change schedule (one change per day)
Key exclusion criteria (6 listed)
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/ injection) treatment
- Is pregnant or breastfeeding.
- Is participating in other interventional clinical investigations or have previously participated in this investigation
- Have a loop ileostomy
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 |
|---|---|---|
| Test AOstomy appliance | Device | Baseline - Test A - Test B, Baseline - Test B - Test A |
| Test BOstomy appliance | Device | Baseline - Test A - Test B, Baseline - Test B - Test A |
| BaselineOstomy appliance | Device | Baseline - Test A - Test B, Baseline - Test B - Test A |
Primary outcome
Product Acceptance
Time frame: 7 days per test period
Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products. There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate. The result presented below shows how many subjects preferred Test A/Test B over own product
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- 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 Petersen Jakobsen, MD principal investigator
Coloplast A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test A, Test B and Baseline in people with Ileostomy, run by Coloplast A/S at 1 site in Denmark.
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 10 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: finished, as of the sponsor's last update on 6 Jan 2016. 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 Denmark. 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?
Yes. Results are posted in the registry (first posted 30 Nov 2015). 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?
Product Acceptance (time frame: 7 days per test period). 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 6 Jan 2016.