LeakagePhase 3NCT01517178
Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care
A Phase 3 study testing New ostomy base plate (SS) in people with Leakage and Skin Condition, run by Coloplast A/S at 11 sites in 4 countries.
Trial summary
The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leakage, Skin Condition
- What is being tested?
- New ostomy base plate (SS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 11 sitesin 4 countries
- Study dates
- May 2011to Jun 2011
- Phase
- Phase 3
- 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
- Is at least 18 years old
- Has the mental capacity to understand the study guidelines and questionnaires
- Has had their ileostomy for at least 3 months
- Has an ileostomy with a diameter between 19-40 mm
- Is currently using a flat 2-piece product with with mechanical coupling
- Is able to change the base plate by themselves or with help from a caregiver (e.g. spouse)
- Has experienced leakage under the base plate at least once a week over the last 2 weeks
Who cannot join
- Is pregnant or breast-feeding
- Currently receiving or has within the past 2 months received radio- and/or chemotherapy
- Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted)
- Is currently using a convex base plate
- Participating in other clinical studies or has previously participated in this study
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
France5 sites
Hôpital Nord
Marseille, 13015
Hôpital Hôtel Dieu de Nantes
Nantes, 44093
Hôpital Lariboisière
Paris, 75475
CHRU La Milétrie
Poitiers, 86021
Hôpital de Pontchaillou, CHRU de Rennes
Rennes, 35033
Denmark4 sites
Sygehus Sønderjylland i Aabenraa
Aabenraa, 6200
Bispebjerg Hospital
Copenhagen, 2400
Hvidovre Hospital
Hvidovre, 2650
Odense Universitetshospital
Odense, 5000
About this study
Official title: An Open-labelled, Randomised, Controlled, Comparative, Multi-national, Cross-over Study Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared to 2-piece Standard Care Ostomy Products
The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.
The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates.
Read more
The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates.
Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods.
The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period.
100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.
- Conditions
- Leakage, Skin Condition
- Being tested
- New ostomy base plate (SS), Standard Care base plate
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New ostomy base plate (SS)Device
The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
Standard Care base plateDevice
The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care base plate | Active comparator | Standard care are the participants own product and can have several manufacture and brand names Receives: Device: Standard Care base plate |
| New ostomy base plate (SS) | Experimental | SS = New ostomy base plate. Due to company confidentiality the product is called SS and this is not short for any name Receives: Device: New ostomy base plate (SS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Output Under the Base Plate (Leakage).
Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).
Measured: Each test product was assessed for 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJun 2011
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 LeakageStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT01517178
- Sponsor's protocol ID
- CP215OC
- Status last verified
- Mar 2015
- First submitted
- 24 Jun 2011
- Last updated
- 13 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 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labelled, Randomised, Controlled, Comparative, Multi-national, Cross-over Study Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared to 2-piece Standard Care Ostomy Products
- ClinicalTrials.gov ID
- NCT01517178
- Acronym / sponsor ID
- CP215OC
- Conditions
- Leakage, Skin Condition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Posted 13 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 primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.
The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates.
The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates.
Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods.
The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period.
100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care base plate | Active comparator | Device: Standard Care base plateStandard care are the participants own product and can have several manufacture and brand names |
| New ostomy base plate (SS) | Experimental | Device: New ostomy base plate (SS)SS = New ostomy base plate. Due to company confidentiality the product is called SS and this is not short for any name |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have given written Informed Consent
- Is at least 18 years old
- Has the mental capacity to understand the study guidelines and questionnaires
- Has had their ileostomy for at least 3 months
- Has an ileostomy with a diameter between 19-40 mm
Key exclusion criteria (5 listed)
- Is pregnant or breast-feeding
- Currently receiving or has within the past 2 months received radio- and/or chemotherapy
- Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted)
- Is currently using a convex base plate
- Participating in other clinical studies or has previously participated in this study
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 |
|---|---|---|
| New ostomy base plate (SS)The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate. | Device | New ostomy base plate (SS) |
| Standard Care base plateThe base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate. | Device | Standard Care base plate |
Primary outcome
Degree of Output Under the Base Plate (Leakage).
Time frame: Each test product was assessed for 2 weeks.
Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
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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.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing New ostomy base plate (SS) in people with Leakage and Skin Condition, run by Coloplast A/S at 11 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 8 inclusion and 5 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 13 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 11 sites in France, Denmark, Germany, Iceland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 13 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?
Degree of Output Under the Base Plate (Leakage). (time frame: Each test product was assessed for 2 weeks.). 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 13 Mar 2015.