IleostomyNCT02675634
Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy
A study testing Coloplast Test A, Coloplast Test B and Subjects own product in people with Ileostomy and Colostomy, run by Coloplast A/S at 12 sites in 4 countries.
Trial summary
This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Coloplast Test A, Coloplast Test B and Subjects own product
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Jan 2016to Jun 2016
- 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
- 1. Have given written informed consent and in DK: signed a letter of authority 2. Are at least 18 years of age and have full legal capacity 3. Have had their ileostomy or colostomy for at least 3 months 4. Are able to use a baseplate cut-max 15 to 40 mm 5. Are able to handle the product themselves 6. Currently using a 1-piece flat product 8. Willing to use an open bag size maxi during the investigation 9. Are able to use a custom cut (custom fit) product 10. Are suitable for participating in the investigation - this means that the subjects must be able to follow all elements of the study procedures.
Who cannot join
- Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
- Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
- Are pregnant or breastfeeding**
- Are participating in other interventional clinical investigations or have previously participated in this investigation
- Use irrigation during the investigation (flush the intestines with water, this is mostly for people with a colostomy)
- Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
Show all 9Show fewer
- Have a loop ostomy (also called double barrel ostomy)
- Have known hypersensitivity towards any of the products used in the investigation
- In DK: women in the child-bearing age will be ask to produce a negative pregnancy test and to sign a form ensuring the use of safe contraception during the investigation.
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United Kingdom7 sites
Synexus Midlands
Birmingham, B15 2SQ
Pilgrim Hospital
Boston
Illingworth Research Nurses
Cheshire, Sk11 6TG
Lincon Country hospital
Lincoln, LN25QY
Aintree University Hospital NHS Foundation Trust
Liverpool, l9 7AL
Kettering General hospital
Northamptonshire, NN168UZ
Synexus Hexam
Northumberland, NE46 1QJ
United States3 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Prism research center
Saint Paul, Minnesota, 55114
Radiant Research
Tempe, Arizona, 85282
About this study
This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.
- Being tested
- Coloplast Test A, Coloplast Test B, Subjects own product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast Test ADevice
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Coloplast Test BDevice
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Subjects own productDevice
The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.
| Study group | Role | What they receive |
|---|---|---|
| Test A, Test B, Subjects own product | Experimental | The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product Receives: Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product |
| Test A, Subjects own product, Test B | Experimental | The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B Receives: Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product |
| Test B, Test A, Subjects own product | Experimental | The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product Receives: Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product |
| Test B, Subjects own product, Test A | Experimental | The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A Receives: Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product |
| Subjects own product, Test A, Test B | Experimental | The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B Receives: Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product |
| Subjects own product, Test B, Test A | Experimental | The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A Receives: Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fit to Body
Subjects will evaluate the fit to body for each product by answering the question "how was the baseplates ability to fit the body contours in the area around the stoma?" The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question.
Measured: 14 +/- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Camilla F Vibjerg, Study chair, Head of Clinical Operation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675634
- Sponsor's protocol ID
- CP266
- Status last verified
- Sep 2017
- First submitted
- 29 Jan 2016
- Last updated
- 16 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy
- ClinicalTrials.gov ID
- NCT02675634
- Acronym / sponsor ID
- CP266
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Posted 5 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Test A, Test B, Subjects own product | Experimental | Device: Coloplast Test A, Device: Coloplast Test B, Device: Subjects own productThe subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product |
| Test A, Subjects own product, Test B | Experimental | Device: Coloplast Test A, Device: Coloplast Test B, Device: Subjects own productThe subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B |
| Test B, Test A, Subjects own product | Experimental | Device: Coloplast Test A, Device: Coloplast Test B, Device: Subjects own productThe subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product |
| Test B, Subjects own product, Test A | Experimental | Device: Coloplast Test A, Device: Coloplast Test B, Device: Subjects own productThe subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A |
| Subjects own product, Test A, Test B | Experimental | Device: Coloplast Test A, Device: Coloplast Test B, Device: Subjects own productThe subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B |
| Subjects own product, Test B, Test A | Experimental | Device: Coloplast Test A, Device: Coloplast Test B, Device: Subjects own productThe subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Have given written informed consent and in DK: signed a letter of authority 2. Are at least 18 years of age and have full legal capacity 3. Have had their ileostomy or colostomy for at least 3 months 4. Are able to use a baseplate cut-max 15 to 40 mm 5. Are able to handle the product themselves 6. Currently using a 1-piece flat product 8. Willing to use an open bag size maxi during the investigation 9. Are able to use a custom cut (custom fit) product 10. Are suitable for participating in the investigation - this means that the subjects must be able to follow all elements of the study procedures.
Key exclusion criteria (9 listed)
- Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
- Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
- Are pregnant or breastfeeding**
- Are participating in other interventional clinical investigations or have previously participated in this investigation
- Use irrigation during the investigation (flush the intestines with water, this is mostly for people with a colostomy)
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 ATest A is a new 1-piece ostomy appliance developed by Coloplast A/S | Device | Subjects own product, Test A, Test B, Subjects own product, Test B, Test A, Test A, Subjects own product, Test B, Test A, Test B, Subjects own product, Test B, Subjects own product, Test A, Test B, Test A, Subjects own product |
| Coloplast Test BTest B is a new 1-piece ostomy appliance developed by Coloplast A/S | Device | Subjects own product, Test A, Test B, Subjects own product, Test B, Test A, Test A, Subjects own product, Test B, Test A, Test B, Subjects own product, Test B, Subjects own product, Test A, Test B, Test A, Subjects own product |
| Subjects own productThe comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group. | Device | Subjects own product, Test A, Test B, Subjects own product, Test B, Test A, Test A, Subjects own product, Test B, Test A, Test B, Subjects own product, Test B, Subjects own product, Test A, Test B, Test A, Subjects own product |
Primary outcome
Fit to Body
Time frame: 14 +/- 2 days
Subjects will evaluate the fit to body for each product by answering the question "how was the baseplates ability to fit the body contours in the area around the stoma?" The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Camilla F Vibjerg study chair
Head of Clinical Operation
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coloplast Test A, Coloplast Test B and Subjects own product in people with Ileostomy and Colostomy, run by Coloplast A/S at 12 sites in 4 countries.
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 1 inclusion and 9 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 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, United States, Denmark, Netherlands. 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 5 Sep 2017). 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?
Fit to Body (time frame: 14 +/- 2 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 16 Oct 2017.