Ileostomy - StomaNCT01799239
Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura
A study testing Test product and SenSura in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Sweden.
Trial summary
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film. 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?
- Test product and SenSura
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2013to Mar 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
- Be at least 18 years of age and have full legal capacity
- Be able to handle the bags themselves
- Have an ileostomy with a diameter between 15 and 55 mm
- Have had their ileostomy for at least 3 months
- Currently use a 1-piece flat ostomy appliance with open bag
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- Use minimum 1 product every second day, i.e. maximum 2 days wear time
- Be suitable for participation in the study and for using a standard adhesive, flat base plate
- Must be able and willing to use custom cut products
- Accept to test two 1-piece products within the study period
Who cannot join
- Use irrigation during the study period (flush the intestines with water)
- Currently receiving or have within the past 2 months received chemotherapy or radiation therapy
- Currently receiving or have within the past month received systematic 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
- Currently using a ostomy belt
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- Currently using extended wear product
- Have a loop ileostomy
- Known hypersensitivity towards any of the test products
- Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Safety and Performance of Newly Developed 1-piece Ostomy Product Concept Compared With SenSura 1-piece in Subjects With an Ileostomy
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.
- Conditions
- Ileostomy - Stoma
- Being tested
- Test product, SenSura
- Keywords
- stoma ileostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test productDevice
The test product consists of an adhesive with a new top film
SenSuraDevice
SenSura is the CE-marked and commercially available comparator product
| Study group | Role | What they receive |
|---|---|---|
| First Test product; then SenSura | Experimental | The subject in this arm first test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details.
After cross-over the subject test SenSura which is CE-marked and commerical available. Receives: Device: Test product; Device: SenSura |
| First SenSura, Then Test product | Active comparator | The subject in this arm first test SenSura which is CE-marked and commerical available.
After cross-over the subject test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details. Receives: Device: Test product; Device: SenSura |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage (Percentage of All Baseplates With Leakage)
leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate.
The subjects tick of one of the four possible answers:
- No leakage
- Starting to leak (leakage under the baseplate)
- Leakage (seepage of faeces resulting in leakage on clothes)
- Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)
Measured: After each baseplate change over a period, of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2013
- Study completionMar 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Carter, MSc, Study chair, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799239
- Sponsor's protocol ID
- CP237
- Status last verified
- Aug 2016
- First submitted
- 22 Feb 2013
- Last updated
- 30 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 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Safety and Performance of Newly Developed 1-piece Ostomy Product Concept Compared With SenSura 1-piece in Subjects With an Ileostomy
- ClinicalTrials.gov ID
- NCT01799239
- Acronym / sponsor ID
- CP237
- Conditions
- Ileostomy - Stoma
- Keywords
- stoma ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Posted 5 Dec 2013
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 evaluate the combination of an adhesive with a soft top film.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Test product; then SenSura | Experimental | Device: Test product, Device: SenSuraThe subject in this arm first test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details. After cross-over the subject test SenSura which is CE-marked and commerical available. |
| First SenSura, Then Test product | Active comparator | Device: Test product, Device: SenSuraThe subject in this arm first test SenSura which is CE-marked and commerical available. After cross-over the subject test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details. |
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 bags themselves
- Have an ileostomy with a diameter between 15 and 55 mm
- Have had their ileostomy for at least 3 months
Key exclusion criteria (10 listed)
- Use irrigation during the study period (flush the intestines with water)
- Currently receiving or have within the past 2 months received chemotherapy or radiation therapy
- Currently receiving or have within the past month received systematic 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 |
|---|---|---|
| Test productThe test product consists of an adhesive with a new top film | Device | First SenSura, Then Test product, First Test product; then SenSura |
| SenSuraSenSura is the CE-marked and commercially available comparator product | Device | First SenSura, Then Test product, First Test product; then SenSura |
Primary outcome
Leakage (Percentage of All Baseplates With Leakage)
Time frame: After each baseplate change over a period, of 7 days
leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate. The subjects tick of one of the four possible answers: 1. No leakage 2. Starting to leak (leakage under the baseplate) 3. Leakage (seepage of faeces resulting in leakage on clothes) 4. Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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.
Daniel Carter, MSc study chair
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 Test product and SenSura in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Sweden.
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 10 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 30 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 Sweden. 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 5 Dec 2013). 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 (Percentage of All Baseplates With Leakage) (time frame: After each baseplate change over a period, of 7 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 30 Sep 2016.