Stoma - IleostomyNCT01957475
Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy
A study testing Coloplast Test product Y and Coloplast Test product Z in people with Stoma - Ileostomy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma - Ileostomy
- What is being tested?
- Coloplast Test product Y and Coloplast Test product Z
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to May 2013
- 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 signed letter of authority.
- Are at least 18 years of age and have full legal capacity.
- Have had their ileostomy for at least 3 months.
- Have used a 2-piece convex ostomy product during the last month.
- Are willing and able to comply with investigation procedures.
- Have an ileostomy with a diameter of 30 mm or less.
- Have experienced leakage (seeping) under the baseplate at least 2 times during the last two weeks.
Who cannot join
- Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
- Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
- Are pregnant or breastfeeding.
- Have a loop ostomy (also called double-barrel or ostomy with two outlets).
- Known hypersensitivity toward any of the test products.
- Participating in other interventional clinical investigations or have previously participated in this investigation.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances
- Conditions
- Stoma - Ileostomy
- Being tested
- Coloplast Test product Y, Coloplast Test product Z
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast Test product YDevice
Also called Coloplast 2-piece Convex appliance Test product Y
Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance
Coloplast Test product ZDevice
Also called Coloplast 2-piece convex appliance test product Z
Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance
| Study group | Role | What they receive |
|---|---|---|
| First Coloplast Test product Z; then Coloplast Test product Y | Experimental | The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y Receives: Device: Coloplast Test product Y; Device: Coloplast Test product Z |
| First Coloplast Test product Y, Then Coloplast Test product Z | Experimental | The subjects first test test product Y and after cross-over test product Z Receives: Device: Coloplast Test product Y; Device: Coloplast Test product Z |
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 measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome).
The degree of leakage was measured at each baseplate change.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2013
- Study completionMay 2013
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
- 20 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
- NCT01957475
- Sponsor's protocol ID
- CP240
- Status last verified
- Aug 2016
- First submitted
- 6 Aug 2013
- Last updated
- 20 Sep 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 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy
- ClinicalTrials.gov ID
- NCT01957475
- Acronym / sponsor ID
- CP240
- Conditions
- Stoma - Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 11 Aug 2014
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 current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Coloplast Test product Z; then Coloplast Test product Y | Experimental | Device: Coloplast Test product Y, Device: Coloplast Test product ZThe subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y |
| First Coloplast Test product Y, Then Coloplast Test product Z | Experimental | Device: Coloplast Test product Y, Device: Coloplast Test product ZThe subjects first test test product Y and after cross-over test product Z |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have given written informed consent and signed letter of authority.
- Are at least 18 years of age and have full legal capacity.
- Have had their ileostomy for at least 3 months.
- Have used a 2-piece convex ostomy product during the last month.
- Are willing and able to comply with investigation procedures.
Key exclusion criteria (7 listed)
- Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
- Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
- Are pregnant or breastfeeding.
- Have a loop ostomy (also called double-barrel or ostomy with two outlets).
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 product YAlso: Coloplast 2-piece Convex appliance Test product YColoplast Test product Y is a newly developed 2-piece convex ostomy appliance | Device | First Coloplast Test product Y, Then Coloplast Test product Z, First Coloplast Test product Z; then Coloplast Test product Y |
| Coloplast Test product ZAlso: Coloplast 2-piece convex appliance test product ZColoplast Test product Z is a newly developed 2-piece convex ostomy appliance | Device | First Coloplast Test product Y, Then Coloplast Test product Z, First Coloplast Test product Z; then Coloplast Test product Y |
Primary outcome
Degree of Leakage
Time frame: 14 days
The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome). The degree of leakage was measured at each baseplate change.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 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 product Y and Coloplast Test product Z in people with Stoma - 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 7 inclusion and 7 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 20 Sep 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 11 Aug 2014). 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 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 20 Sep 2016.