Stoma IleostomyNCT02043782
Investigation of a New 1-piece Convex Ostomy Product
A study testing Coloplast Test, Own product and Competitor soft convex in people with Stoma Ileostomy and Stoma Colostomy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The aim of the investigation was to investigate the performance and safety of a new ostomy product Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Ileostomy, Stoma Colostomy
- What is being tested?
- Coloplast Test, Own product and Competitor soft convex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Apr 2014
- 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
- Are at least 18 years of age and have full legal capacity.
- Have had an ileostomy/colostomy for more than 3 months
- Have used a 1-piece flat ostomy product for the last 1 month
- Has given written Informed Consent and signed the letter of authority
- Have an ileostomy or colostomy with a diameter of 33 mm or less
- Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
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- Are evaluated to be suitable for a soft convex product
- If having a colostomy: changes their product on average 2 times pr. 24h or more
- Currently uses a bag of size medi/midi or maxi
Who cannot join
- Have a loop ostomy (also called double-barrel or ostomy with two outlets).
- Are pregnant or breastfeeding
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area
- Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
- Known hypersensitivity toward any of the test products
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- Participating in other interventional clinical investigations or have previously participated in this investigation
- Use irrigation during the investigation (flush the intestine with water)
- Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate
- If subject has a colostomy: empties the bag
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of a New 1-piece Convex Ostomy Product in Subjects With Ileostomy and Colostomy
The aim of the investigation was to investigate the performance and safety of a new ostomy product
- Conditions
- Stoma Ileostomy, Stoma Colostomy
- Being tested
- Coloplast Test, Own product, Competitor soft convex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast TestDevice
Newly developed 1-piece convex ostomy product
Own productDevice
The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more.
Competitor soft convexDevice
A commercially available soft convex product
| Study group | Role | What they receive |
|---|---|---|
| First Coloplast Test | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.
First subjects are allocated to Coloplast Test; Secondly to either
1. Own product (baseline)
2. Competitor soft convex Receives: Device: Coloplast Test; Device: Own product; Device: Competitor soft convex |
| First Competitor soft convex | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.
First subjects are allocated to Competitor soft convex; Secondly to either
1. Own product (baseline)
2. Coloplast Test Receives: Device: Coloplast Test; Device: Own product; Device: Competitor soft convex |
| First Own product | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.
First subjects are allocated to Own product; Secondly to either
1. Coloplast Test
2. Competitor soft convex Receives: Device: Coloplast Test; Device: Own product; Device: Competitor soft convex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Leakage
The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.
Measured: 14 +/- 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
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 Stoma 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
- 38 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, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043782
- Sponsor's protocol ID
- CP241
- Status last verified
- Mar 2016
- First submitted
- 16 Jan 2014
- Last updated
- 4 May 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 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a New 1-piece Convex Ostomy Product in Subjects With Ileostomy and Colostomy
- ClinicalTrials.gov ID
- NCT02043782
- Acronym / sponsor ID
- CP241
- Conditions
- Stoma Ileostomy, Stoma Colostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Posted 8 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the investigation was to investigate the performance and safety of a new ostomy product
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First Coloplast Test | Experimental | Device: Coloplast Test, Device: Own product, Device: Competitor soft convexThe subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Coloplast Test; Secondly to either 1. Own product (baseline) 2. Competitor soft convex |
| First Competitor soft convex | Experimental | Device: Coloplast Test, Device: Own product, Device: Competitor soft convexThe subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Competitor soft convex; Secondly to either 1. Own product (baseline) 2. Coloplast Test |
| First Own product | Experimental | Device: Coloplast Test, Device: Own product, Device: Competitor soft convexThe subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Own product; Secondly to either 1. Coloplast Test 2. Competitor soft convex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Are at least 18 years of age and have full legal capacity.
- Have had an ileostomy/colostomy for more than 3 months
- Have used a 1-piece flat ostomy product for the last 1 month
- Has given written Informed Consent and signed the letter of authority
- Have an ileostomy or colostomy with a diameter of 33 mm or less
Key exclusion criteria (10 listed)
- Have a loop ostomy (also called double-barrel or ostomy with two outlets).
- Are pregnant or breastfeeding
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area
- Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
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 TestNewly developed 1-piece convex ostomy product | Device | First Coloplast Test, First Competitor soft convex, First Own product |
| Own productThe subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more. | Device | First Coloplast Test, First Competitor soft convex, First Own product |
| Competitor soft convexA commercially available soft convex product | Device | First Coloplast Test, First Competitor soft convex, First Own product |
Primary outcome
Degree of Leakage
Time frame: 14 +/- 3 days
The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 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 P 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 Coloplast Test, Own product and Competitor soft convex in people with Stoma Ileostomy and Stoma Colostomy, 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 9 inclusion and 10 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 4 May 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 8 Dec 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?
Degree of Leakage (time frame: 14 +/- 3 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 4 May 2016.