Ostomy - Ileostomy or ColostomyNCT02176954
The Influence of Adhesive Wafer Design on Fit to the Body
A study testing Test A, Test B and Comparator in people with Ostomy - Ileostomy or Colostomy, run by Coloplast A/S at 10 sites in 2 countries.
Trial summary
The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy - Ileostomy or Colostomy
- What is being tested?
- Test A, Test B and Comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jul 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- To participate in the study, it is mandatory that the subject fulfill all inclusions criteria:
- Have given written informed consent and signed letter of Authority
- Be at least 18 years of age and have full legal capacity
- Have had their ileostomy or colostomy for at least 3 months
- Have a stoma with a diameter between 15 and 43 mm
- Be able to handle the product themselves
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- Be able to use a custom cut product
- Normally experience faeces under the adhesive wafer at least 3 times during 2 weeks
- Currently using a 1-piece flat product or a 1-piece soft convex product
- Be willing to test products with open bag size maxi
- Be willing to test Moderma Flex or Confidence® Natural, Drainable and the two test products A and B
- Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per product
- Be suitable for participating in the investigation
- Be willing to take/have taken pictures of the stoma before, during and after application of product
Who cannot join
- Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
- Are currently receiving or have within the past 2 months received radio-and/or chemotherapy
- Are currently receiving or have within the past month received topical steroid treatment in the peri-stomal skin area or systemic steroid (tablet/injection) treatment
- 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)
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- Are currently suffering from peri-stomal skin problems i.e. bleeding and/or broken skin (assessed by the study nurse)
- Have a loop stoma
- Have known hypersensitivity towards any of the test products
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United Kingdom9 sites
Synexus Thames Valley
Berkshire, RG2 0TG
Synexus Midlands
Birmingham, B15 2SQ
Synexus Wales
Cardiff, CF14 5GJ
Synexus Scotland
Glasgow, G20 0SP
Cheltenham General Hospital
Gloucestershire, G1537AN
Synesxus Lancashire
Lancashire, PR7 7NA
Synexus Merseyside
Liverpool, L22 0LG
Synexus Manchester
Manchester, M15 6SX
Synexus North East
Northumberland, NE46 1QJ
About this study
The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..
- Conditions
- Ostomy - Ileostomy or Colostomy
- Being tested
- Test A, Test B, Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test ADevice
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Test BDevice
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
ComparatorDevice
Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.
Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
| Study group | Role | What they receive |
|---|---|---|
| Test A, Test B, Comparator | Experimental | The subjects first test Coloplast Test A followed by Coloplast Test B and finally Comparator. Receives: Device: Test A; Device: Test B; Device: Comparator |
| Test A, Comparator, Test B | Experimental | The subjects first test Coloplast Test A followed by Comparator and finally Coloplast Test B. Receives: Device: Test A; Device: Test B; Device: Comparator |
| Test B, Test A, Comparator | Experimental | The subjects first test Coloplast Test B followed by Coloplast Test A and finally Comparator. Receives: Device: Test A; Device: Test B; Device: Comparator |
| Test B, Comparator, Test A | Experimental | The subjects first test Coloplast Test B followed by Comparator and finally Coloplast Test B. Receives: Device: Test A; Device: Test B; Device: Comparator |
| Comparator, Test A, Test B | Experimental | The subjects first test Comparator followed by Coloplast Test A and then Coloplast Test B Receives: Device: Test A; Device: Test B; Device: Comparator |
| Comparator, Test B, Test A | Experimental | The subjects first test Comparator followed by Coloplast Test B and then Coloplast Test A. Receives: Device: Test A; Device: Test B; Device: Comparator |
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 base plates ability to fit the body contours in the area around the stoma?"
The question is answered with a 5-point scale ranging from Very Poor - Very Good (1-5), where the very poor (1) is the worst possible score and very good (5) is the best possible score.
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 posted27 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ostomy - Ileostomy or ColostomyStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khalid Abd-Elaziz, MD, Principal investigator, QPS NetherlandsSusanne Eyre, MD, Principal investigator, Synexus North East, United KingdomGillian Hopkins, Principal investigator, Cheltenham General Hospital, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176954
- Sponsor's protocol ID
- CP247
- Status last verified
- Mar 2015
- First submitted
- 26 Jun 2014
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Adhesive Wafer Design on Fit to the Body
- ClinicalTrials.gov ID
- NCT02176954
- Acronym / sponsor ID
- CP247
- Conditions
- Ostomy - Ileostomy or Colostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Jun 2014 (estimated)
- 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.
The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..
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, Comparator | Experimental | Device: Test A, Device: Test B, Device: ComparatorThe subjects first test Coloplast Test A followed by Coloplast Test B and finally Comparator. |
| Test A, Comparator, Test B | Experimental | Device: Test A, Device: Test B, Device: ComparatorThe subjects first test Coloplast Test A followed by Comparator and finally Coloplast Test B. |
| Test B, Test A, Comparator | Experimental | Device: Test A, Device: Test B, Device: ComparatorThe subjects first test Coloplast Test B followed by Coloplast Test A and finally Comparator. |
| Test B, Comparator, Test A | Experimental | Device: Test A, Device: Test B, Device: ComparatorThe subjects first test Coloplast Test B followed by Comparator and finally Coloplast Test B. |
| Comparator, Test A, Test B | Experimental | Device: Test A, Device: Test B, Device: ComparatorThe subjects first test Comparator followed by Coloplast Test A and then Coloplast Test B |
| Comparator, Test B, Test A | Experimental | Device: Test A, Device: Test B, Device: ComparatorThe subjects first test Comparator followed by Coloplast Test B and then 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 (14 listed)
- To participate in the study, it is mandatory that the subject fulfill all inclusions criteria:
- Have given written informed consent and signed letter of Authority
- Be at least 18 years of age and have full legal capacity
- Have had their ileostomy or colostomy for at least 3 months
- Have a stoma with a diameter between 15 and 43 mm
Key exclusion criteria (9 listed)
- Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
- Are currently receiving or have within the past 2 months received radio-and/or chemotherapy
- Are currently receiving or have within the past month received topical steroid treatment in the peri-stomal skin area or systemic steroid (tablet/injection) treatment
- Are pregnant or breastfeeding
- Are participating in other interventional clinical investigations or have 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 |
|---|---|---|
| Test ATest A is a new 1-piece ostomy appliance developed by Coloplast A/S | Device | Comparator, Test A, Test B, Comparator, Test B, Test A, Test A, Comparator, Test B, Test A, Test B, Comparator, Test B, Comparator, Test A, Test B, Test A, Comparator |
| Test BTest B is a new 1-piece ostomy appliance developed by Coloplast A/S | Device | Comparator, Test A, Test B, Comparator, Test B, Test A, Test A, Comparator, Test B, Test A, Test B, Comparator, Test B, Comparator, Test A, Test B, Test A, Comparator |
| ComparatorTwo comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available. Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed. | Device | Comparator, Test A, Test B, Comparator, Test B, Test A, Test A, Comparator, Test B, Test A, Test B, Comparator, Test B, Comparator, Test A, Test B, Test A, Comparator |
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 base plates ability to fit the body contours in the area around the stoma?" The question is answered with a 5-point scale ranging from Very Poor - Very Good (1-5), where the very poor (1) is the worst possible score and very good (5) is the best possible score.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
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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.
Khalid Abd-Elaziz, MD principal investigator
QPS Netherlands
Susanne Eyre, MD principal investigator
Synexus North East, United Kingdom
Gillian Hopkins principal investigator
Cheltenham General Hospital, United Kingdom
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test A, Test B and Comparator in people with Ostomy - Ileostomy or Colostomy, run by Coloplast A/S at 10 sites in 2 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 14 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 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 23 Mar 2015.