LeakageNCT01523756
A Clinical Investigation of New Ostomy Appliances
A study testing test product 1: new ostomy base plate with Coloplast as manufacturer and test product 2: new ostomy base plate with Coloplast as manufacturer in people with Leakage, run by Coloplast A/S at 1 site in Denmark.
Trial summary
This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leakage
- What is being tested?
- test product 1: new ostomy base plate with Coloplast as manufacturer and test product 2: new ostomy base plate with Coloplast as manufacturer
- 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
- Feb 2012to Apr 2012
- 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
- Age > 18 years.
- Have had an ileostomy for more than 3 months.
- Have used convex products for the last 1 month.
- Has given written Informed Consent.
- Have an ileostomy with a diameter between 15 and 33 mm.
- Have inward peristomal area
Who cannot join
- Have loop ostomy
- Pregnant or breastfeeding.
- Known allergy towards any of the product components or ingredients.
- Currently receiving or have within the last 2 months received radio- and/or chemotherapy.
- Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
- Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-labelled Randomized Cross-over and Controlled Exploratory Investigation Comparing Several Variants of a Newly Developed Ostomy Appliance With Regard to Performance in 20 Patients With Ileostomy
This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.
- Conditions
- Leakage
- Being tested
- test product 1: new ostomy base plate with Coloplast as manufacturer, test product 2: new ostomy base plate with Coloplast as manufacturer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test product 1: new ostomy base plate with Coloplast as manufacturerDevice
test product 1 is tested first
test product 2: new ostomy base plate with Coloplast as manufacturerDevice
test product 2 is tested first
| Study group | Role | What they receive |
|---|---|---|
| test product 1 first | Experimental | own product (baseline) - test product 1 - test product 2
test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1 Receives: Device: test product 1: new ostomy base plate with Coloplast as manufacturer |
| test product 2 first | Experimental | own product (baseline) - test product 2 - test product 1
test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2 Receives: Device: test product 2: new ostomy base plate with Coloplast as manufacturer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage Under the Base Plate Using a 24-point Scale
Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)
Measured: Each product will be tested 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionApr 2012
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 N/A
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523756
- Sponsor's protocol ID
- CP226
- Status last verified
- Jan 2014
- First submitted
- 10 Jan 2012
- Last updated
- 10 Mar 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 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labelled Randomized Cross-over and Controlled Exploratory Investigation Comparing Several Variants of a Newly Developed Ostomy Appliance With Regard to Performance in 20 Patients With Ileostomy
- ClinicalTrials.gov ID
- NCT01523756
- Acronym / sponsor ID
- CP226
- Conditions
- Leakage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Posted 10 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test product 1 first | Experimental | Device: test product 1: new ostomy base plate with Coloplast as manufacturerown product (baseline) - test product 1 - test product 2 test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1 |
| test product 2 first | Experimental | Device: test product 2: new ostomy base plate with Coloplast as manufacturerown product (baseline) - test product 2 - test product 1 test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years.
- Have had an ileostomy for more than 3 months.
- Have used convex products for the last 1 month.
- Has given written Informed Consent.
- Have an ileostomy with a diameter between 15 and 33 mm.
Key exclusion criteria (6 listed)
- Have loop ostomy
- Pregnant or breastfeeding.
- Known allergy towards any of the product components or ingredients.
- Currently receiving or have within the last 2 months received radio- and/or chemotherapy.
- Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
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 product 1: new ostomy base plate with Coloplast as manufacturertest product 1 is tested first | Device | test product 1 first |
| test product 2: new ostomy base plate with Coloplast as manufacturertest product 2 is tested first | Device | test product 2 first |
Primary outcome
Leakage Under the Base Plate Using a 24-point Scale
Time frame: Each product will be tested 2 weeks
Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
- 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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Surgical Intuition in Anastomotic Leakage After Colorectal Surgery
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Perioperative Biomarkers in Colorectal and Gastric 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.
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 1: new ostomy base plate with Coloplast as manufacturer and test product 2: new ostomy base plate with Coloplast as manufacturer in people with Leakage, 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 6 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: finished, as of the sponsor's last update on 10 Mar 2014. 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 10 Mar 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?
Leakage Under the Base Plate Using a 24-point Scale (time frame: Each product will be tested 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 10 Mar 2014.