IleostomyNCT02362360
Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
A study testing Coloplast Test Product and Comparator (Hollister) in people with Ileostomy and Colostomy, run by Coloplast A/S at 5 sites in 4 countries.
Trial summary
The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Coloplast Test Product and Comparator (Hollister)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Feb 2015to May 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 in DK: signed a 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
- Able to use a baseplate size 15 to 40 mm
- Be able to handle the product themselves
- Normally experience faeces under the baseplate at least 3 times during 2 weeks
Show all 13Show fewer
- Currently using a 2-piece flat product with mechanical coupling
- Willing to test both the Coloplast test product and the comparator product
- Willing to use an open bag size maxi during the investigation
- Willing to use Coloplast test product and comparator products without initial use of accessories (except tube paste / belt)
- Willing to use at least 1 baseplate every 3rd day during the investigation
- Is able to use a custom cut product
- Be suitable for participating in the investigation
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)
- Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment 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)
- Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
- Have a loop ostomy
- Have known hypersensitivity towards any of the products used in the investigation
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Germany2 sites
Charité - Universitätsmedizin Berlin, Klinik für Allgemein-, Gefäß- und Thoraxchirurgie
Berlin, 12203
SIEWA Coloplast Homecare
Hamburg, 22045
About this study
The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.
- Being tested
- Coloplast Test Product, Comparator (Hollister)
- Keywords
- Ostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast Test ProductDevice
A new 2-piece ostomy appliance developed by Coloplast A/S
Comparator (Hollister)Device
Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.
| Study group | Role | What they receive |
|---|---|---|
| Coloplast Test Product then Comparator | Experimental | The subject first tests the Coloplast Test Product and then tests the Comparator Receives: Device: Coloplast Test Product; Device: Comparator (Hollister) |
| Comparator then Coloplast Test Product | Experimental | The subject first tests the Comparator and then tests the Coloplast Test Product. Receives: Device: Coloplast Test Product; Device: Comparator (Hollister) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".
Subjects will evaluate the fit to body for each product by answering the question "How was the baseplates ability to fit to the body contours in the area around the stoma?". The question is answered with a 5-point scale ranging from "very poor" to "very good".
Measured: 21 +/- 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionMay 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362360
- Sponsor's protocol ID
- CP255
- Status last verified
- Aug 2016
- First submitted
- 9 Feb 2015
- Last updated
- 11 Oct 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 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
- ClinicalTrials.gov ID
- NCT02362360
- Acronym / sponsor ID
- CP255
- Keywords
- Ostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Posted 11 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coloplast Test Product then Comparator | Experimental | Device: Coloplast Test Product, Device: Comparator (Hollister)The subject first tests the Coloplast Test Product and then tests the Comparator |
| Comparator then Coloplast Test Product | Experimental | Device: Coloplast Test Product, Device: Comparator (Hollister)The subject first tests the Comparator and then tests the Coloplast Test Product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Have given written informed consent and in DK: signed a 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
- Able to use a baseplate size 15 to 40 mm
- Be able to handle the product themselves
Key exclusion criteria (8 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)
- Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment 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)
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 ProductA new 2-piece ostomy appliance developed by Coloplast A/S | Device | Coloplast Test Product then Comparator, Comparator then Coloplast Test Product |
| Comparator (Hollister)Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag. | Device | Coloplast Test Product then Comparator, Comparator then Coloplast Test Product |
Primary outcome
Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".
Time frame: 21 +/- 3 days
Subjects will evaluate the fit to body for each product by answering the question "How was the baseplates ability to fit to the body contours in the area around the stoma?". The question is answered with a 5-point scale ranging from "very poor" to "very good".
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 Product and Comparator (Hollister) in people with Ileostomy and Colostomy, run by Coloplast A/S at 5 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 13 inclusion and 8 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 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Denmark, Netherlands, Norway. 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 11 Oct 2016). 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 the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good". (time frame: 21 +/- 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 11 Oct 2016.