Ileostomy - StomaNCT01957553
Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece
A study testing Coloplast test product and SenSura in people with Ileostomy - Stoma, run by Coloplast A/S at 17 sites in 5 countries.
Trial summary
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product 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 and SenSura
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Sep 2013to Dec 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
- 1.Have given written informed consent and letter of authority (DK only)
- 2.Be at least 18 years of age and have full legal capacity.
- 3.Be able to handle the products her/himself
- 4.Have an ileostomy with a diameter between 10 and 40 mm.
- 5.Have had their ostomy for at least three months.
- 6.Be willing to use minimum 2 base plates every week
- 7.Currently use 2-piece flat mechanical coupling product with open bag 8
- 11.Negative result of a pregnancy test for women of childbearing age (only DK)
Who cannot join
- 1.Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- 2.Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- 3.Is pregnant or breastfeeding.
- 4.Is participating in other interventional clinical investigations or have previously participated in this investigation
- 5.Has participated in the previous explorative study CP234
- 6.
- 7.Known hypersensitivity towards any of the test products
- 8.Currently suffering from peristomal skin problems (i.e.bleeding or red and broken skin)
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Sweden7 sites
Länssjukhhuset gävle, Stomimottagningen
Gävle, 801 87
Kirug kliniken Centralsjukhuset
Karlstad, 651 85
Kirurgens Mottagning
Malmö, 205 02
Capio St. Görans Sjukhus AB, kirurgkliniken
Stockholm, 112 45
Södersjukhuset
Stockholm, 117 61
karolinska Universitetssjukhuset Solna Stomimottagningen
Stockholm, 171 76
Stomimottagningen Centrllasarette i Västerås
Västerås, 721 89
Denmark6 sites
Aabenraa Stomi Ambulatorie, Sygehus Sønderjylland
Aabenraa, 6200
Coloplast A/S
Humlebæk, 3050
Stomiambulatoriet, Kolding Sygehus
Kolding, 6000
Stomiambulatoriet A5, Odense Hospital
Odense C, 5000
Kirurgisk ambulatorium/Stomiambulatoriet OUH
Svendborg, 5700
Vejle Sygehus, Stomiambulatoriet B120
Vejle, 7100
Norway2 sites
Gastrokirurgisk Sekjon, Kirurgisk Klinikk Haugesund Sjukhus
Haugesund, 5504
Helse Nordbyen
Larvik, 3269
About this study
Official title: Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click in 130 Subjects With an Ileostomy.
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
Read the detailed description
The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.
- Conditions
- Ileostomy - Stoma
- Being tested
- Coloplast test product, SenSura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast test productDevice
Coloplast test product is a newly developed 2-piece ostomy appliance
SenSuraDevice
Also called SenSura Click, SenSura Standard 2-piece
SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1, First Coloplast Test product | Experimental | Subjects first allocated to Coloplast Test product will after cross-over test SenSura Receives: Device: Coloplast test product; Device: SenSura |
| Treatment seqence 2; First SenSura | Experimental | Subjects first allocated to SenSura will after cross-over test Coloplast Test product Receives: Device: Coloplast test product; Device: SenSura |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference
The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura.
Measured: 21+1 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 startSep 2013
- Primary completionDec 2013
- Study completionDec 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 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 130 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
- NCT01957553
- Sponsor's protocol ID
- CP243
- Status last verified
- Sep 2014
- First submitted
- 1 Oct 2013
- Last updated
- 8 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click in 130 Subjects With an Ileostomy.
- ClinicalTrials.gov ID
- NCT01957553
- Acronym / sponsor ID
- CP243
- Conditions
- Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 8 Sep 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 investigate the performance of a new 2-piece ostomy product
Detailed description
The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1, First Coloplast Test product | Experimental | Device: Coloplast test product, Device: SenSuraSubjects first allocated to Coloplast Test product will after cross-over test SenSura |
| Treatment seqence 2; First SenSura | Experimental | Device: Coloplast test product, Device: SenSuraSubjects first allocated to SenSura will after cross-over test 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 (8 listed)
- 1.Have given written informed consent and letter of authority (DK only)
- 2.Be at least 18 years of age and have full legal capacity.
- 3.Be able to handle the products her/himself
- 4.Have an ileostomy with a diameter between 10 and 40 mm.
- 5.Have had their ostomy for at least three months.
Key exclusion criteria (8 listed)
- 1.Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- 2.Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- 3.Is pregnant or breastfeeding.
- 4.Is participating in other interventional clinical investigations or have previously participated in this investigation
- 5.Has participated in the previous explorative study CP234
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 productColoplast test product is a newly developed 2-piece ostomy appliance | Device | Treatment seqence 2; First SenSura, Treatment sequence 1, First Coloplast Test product |
| SenSuraAlso: SenSura Click, SenSura Standard 2-pieceSenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S | Device | Treatment seqence 2; First SenSura, Treatment sequence 1, First Coloplast Test product |
Primary outcome
Preference
Time frame: 21+1 days
The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
- 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
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coloplast test product and SenSura in people with Ileostomy - Stoma, run by Coloplast A/S at 17 sites in 5 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 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 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Sweden, Denmark, Norway, Belgium, 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?
Yes. Results are posted in the registry (first posted 8 Sep 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?
Preference (time frame: 21+1 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 8 Sep 2014.