Ileostomy - StomaPhase 2NCT01994863
Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy
A Phase 2 study testing Coloplast Test product in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Netherlands.
Trial summary
The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- Coloplast Test product
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Nov 2012
- Phase
- Phase 2
- 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
- Be at least 18 years of age and have full legal capacity
- Be able to handle the appliance themselves or with help from caregiver (e.g. spouse)
- Have an ileostomy with a diameter between 15 and 45 mm
- Have had their ostomy for at least three months
- Currently use a 1-piece flat product with open bag
Show all 10Show fewer
- Use minimum 1 product every second day.
- Be suitable for participation in the investigation and for using a standard adhesive, flat base plate
- Must use custom cut product
- Accept to test two 1-piece products within the study
Who cannot join
- Use irrigation during the study (flush the stoma with water)
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area
- Are pregnant or breastfeeding
- Participating in other interventional clinical investigations or have previously participated in this investigation
- Has more than three days wear time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-labeled, Randomised, Controlled, Comparative, Cross-over Study Investigating the Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care 1-piece in Subjects With Ileostomy
The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.
- Conditions
- Ileostomy - Stoma
- Being tested
- Coloplast Test product, Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast Test productDevice
Also called Coloplast 1-piece test product
Coloplast test product is a newly developed 1-piece ostomy appliance
Standard CareDevice
Also called Coloplast SenSura, Hollister Moderma/Moderma Flex, B.Braun Flexima/Softima
Standard care consists of three already marketed 1-piece ostomy products
Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima
| Study group | Role | What they receive |
|---|---|---|
| First Coloplast Test product; then Standard Care (see below) | Experimental | The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care.
Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.
The three Standard Care products were tested in a 1:1:1 randomisation. Receives: Device: Coloplast Test product; Device: Standard Care |
| First Standard Care (see below); Then coloplast test product | Experimental | The subjects are randomised to test Standard care first and thereafter test Coloplast test product.
Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.
The three Standard Care products were tested in a 1:1:1 randomisation. Receives: Device: Coloplast Test product; Device: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage
The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
Measured: 14+/-3 days per product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Problems with product performance
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 Ileostomy - StomaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Carter, MSc, Study director, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994863
- Sponsor's protocol ID
- CP224
- Status last verified
- Mar 2015
- First submitted
- 26 Feb 2013
- Last updated
- 11 Mar 2015
- 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 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labeled, Randomised, Controlled, Comparative, Cross-over Study Investigating the Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care 1-piece in Subjects With Ileostomy
- ClinicalTrials.gov ID
- NCT01994863
- Acronym / sponsor ID
- CP224
- Conditions
- Ileostomy - Stoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problems with product performance
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Posted 11 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Coloplast Test product; then Standard Care (see below) | Experimental | Device: Coloplast Test product, Device: Standard CareThe subjects are randomised to test Coloplast Test product first and thereafter test Standard Care. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation. |
| First Standard Care (see below); Then coloplast test product | Experimental | Device: Coloplast Test product, Device: Standard CareThe subjects are randomised to test Standard care first and thereafter test Coloplast test product. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Be able to handle the appliance themselves or with help from caregiver (e.g. spouse)
- Have an ileostomy with a diameter between 15 and 45 mm
- Have had their ostomy for at least three months
Key exclusion criteria (6 listed)
- Use irrigation during the study (flush the stoma with water)
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area
- Are pregnant or breastfeeding
- 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 |
|---|---|---|
| Coloplast Test productAlso: Coloplast 1-piece test productColoplast test product is a newly developed 1-piece ostomy appliance | Device | First Coloplast Test product; then Standard Care (see below), First Standard Care (see below); Then coloplast test product |
| Standard CareAlso: Coloplast SenSura, Hollister Moderma/Moderma Flex, B.Braun Flexima/SoftimaStandard care consists of three already marketed 1-piece ostomy products Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima | Device | First Coloplast Test product; then Standard Care (see below), First Standard Care (see below); Then coloplast test product |
Primary outcome
Leakage
Time frame: 14+/-3 days per product
The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- 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.
Daniel Carter, MSc study director
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 Phase 2 study testing Coloplast Test product in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Netherlands.
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 10 inclusion and 6 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: stopped early, as of the sponsor's last update on 11 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 1 site in 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 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?
Leakage (time frame: 14+/-3 days per product). 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 Mar 2015.