ColostomyPhase 2/3NCT01243294
Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
A Phase 2/3 study testing SS and SenSura in people with Colostomy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colostomy
- What is being tested?
- SS and SenSura
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to Nov 2010
- Phase
- Phase 2/3
- 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
- Be at least 18 years of age and have full legal capacity
- Be able to handle the bags themselves (application, removal)
- Have a colostomy with a diameter less than 45 mm
- Have had a colostomy for at least 3 months
- Currently use a 1-piece flat ostomy appliance with closed bag
Show all 10Show fewer
- is suitable for treatment with a standard adhesive, flat base plate (evaluated by nurse)
- Use minimum 1 product per day
- Be willing to test a new Coloplast one-piece custom cut ostomy appliance size midi or maxi for 10 days and SenSura (1- piece open ostomy bag custom cut ostomy appliance) size midi or maxi for 10 days
- Have the mental capacity to understand the study and questionnaires
Who cannot join
- Use irrigation during the study (flush the stoma with water).
- Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
- Currently receiving or have within the last 2 months received chemotherapy or radiation therapy
- Currently receive or have within the past three weeks been receiving steroid medication in the peristomal area.
- Are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-over, Open Label Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
Read the detailed description
Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems.
To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new ostomy appliance to improve the feeling of security and increase comfort by the appliance characteristics.
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
The study is a randomised controlled cross-over intervention study, where all study participants will test two test products (new ostomy appliance and SenSura). Each test period will last 10 ± 2 days and the subjects will follow their usual wear and change pattern. The participants will visit the study investigator at study start and at cross-over. Evaluation of the test products will occur via questionnaires the subjects fill in at home.
50 healthy subjects with a colostomy will be included in the study.
- Conditions
- Colostomy
- Being tested
- SS, SenSura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSDevice
Also called SenSura, New ostomy appliance
New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.
SenSuraDevice
Also called New ostomy appliance
New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.
| Study group | Role | What they receive |
|---|---|---|
| SenSura | Active comparator | CE marked and launched (The letters "CE" do not represent any specific words, though may have initially stood for "Communauté Européenne" ("European Community") or "Conformité Européenne" ("European Conformity"). By affixing the CE marking to a product, the manufacturer declares that it meets EU safety and health and environmental requirements. Receives: Device: SS; Device: SenSura |
| New ostomy appliance (SS) | Active comparator | SS = New ostomy appliance. Due to company confidentiality the product is just called SS and this is not short for any other names. Receives: Device: SS; Device: SenSura |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage (Percent of All Base Plates With Leakage)
Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point
Measured: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day
Secondary outcomes (5)
Adverse Events
Safety is evaluated by adverse events occuring continues while the subjects are testing the devices
Measured: During the investigation ~ 24 days per subject
Security (Subjects Own Assessment)
Results of participants who answered on own assessment of security on a 5 point scale ('very poor', 'poor', 'acceptable', 'good' and 'very good'). 'Good' and 'very good' are the preferred end points The 'very good' result are presented here.
Unit of measure is: Percentage of participants answering 'very good'
Measured: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product
Handling at Appliance (Subjects Own Assessment)
Handling at appliance where evaluated by subjects own assessment on a 5 point scale from very difficult to very easy.
Results of participants who answered on own feeling of handling at appliance on a 5 point scale (very difficult, difficult, acceptable, easy, very easy). Easy and very easy are the preferred end points and it is the these results that are presented here.
Unit of measure is: Percentage of participants answering 'very easy' and 'easy'
Measured: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product
Comfort (Subjects Own Assessment)
Comfort where evaluated by subjects own assessment on a 5 point scale from very uncomfortable to very comfortable.
Results of participants who answered on own assessment of comfort of wearing the product on a 5 point scale (very uncomfortable, uncomfortable, acceptable, comfortable, very comfortable). Comfortable and very comfortable are the preferred end points and it is these results that are presented here.
Unit of measure is: Percentage of participants answering 'very comfortable' and 'comfortable'
Measured: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product
Wear Time (Registered by Subject When Applying and Removing a Product)
Wear time was calculated from the time the subjects applied their product (date, year, time) to the time they detached the product (date, year, time). Wear time was estimated in hours per subject per base plate and mean value was calculated.
Measured: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2010
- Study completionNov 2010
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 ColostomyStudies 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 2/3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pia Nordmand, MSc, Principal investigator, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243294
- Sponsor's protocol ID
- CP209OC
- Status last verified
- Oct 2011
- First submitted
- 9 Aug 2010
- Last updated
- 7 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-over, Open Label Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
- ClinicalTrials.gov ID
- NCT01243294
- Acronym / sponsor ID
- CP209OC
- Conditions
- Colostomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Posted 22 Jun 2011
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 this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
Detailed description
Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems.
To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new ostomy appliance to improve the feeling of security and increase comfort by the appliance characteristics.
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
The study is a randomised controlled cross-over intervention study, where all study participants will test two test products (new ostomy appliance and SenSura). Each test period will last 10 ± 2 days and the subjects will follow their usual wear and change pattern. The participants will visit the study investigator at study start and at cross-over. Evaluation of the test products will occur via questionnaires the subjects fill in at home.
50 healthy subjects with a colostomy will be included in the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SenSura | Active comparator | Device: SS, Device: SenSuraCE marked and launched (The letters "CE" do not represent any specific words, though may have initially stood for "Communauté Européenne" ("European Community") or "Conformité Européenne" ("European Conformity"). By affixing the CE marking to a product, the manufacturer declares that it meets EU safety and health and environmental requirements. |
| New ostomy appliance (SS) | Active comparator | Device: SS, Device: SenSuraSS = New ostomy appliance. Due to company confidentiality the product is just called SS and this is not short for any other names. |
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 (application, removal)
- Have a colostomy with a diameter less than 45 mm
- Have had a colostomy for at least 3 months
Key exclusion criteria (5 listed)
- Use irrigation during the study (flush the stoma with water).
- Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
- Currently receiving or have within the last 2 months received chemotherapy or radiation therapy
- Currently receive or have within the past three weeks been receiving steroid medication in the peristomal area.
- Are pregnant or breastfeeding
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 |
|---|---|---|
| SSAlso: SenSura, New ostomy applianceNew ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura. | Device | New ostomy appliance (SS), SenSura |
| SenSuraAlso: New ostomy applianceNew ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura. | Device | New ostomy appliance (SS), SenSura |
Primary outcome
Leakage (Percent of All Base Plates With Leakage)
Time frame: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day
Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point
5 secondary outcomes
Adverse Events
Time frame: During the investigation ~ 24 days per subject
Security (Subjects Own Assessment)
Time frame: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product
Handling at Appliance (Subjects Own Assessment)
Time frame: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product
Comfort (Subjects Own Assessment)
Time frame: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product
Wear Time (Registered by Subject When Applying and Removing a Product)
Time frame: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- 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.
Pia Nordmand, MSc principal investigator
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 2/3 study testing SS and SenSura in people with Colostomy, 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 10 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: finished, as of the sponsor's last update on 7 Oct 2011. 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.
What does this combined 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.
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 22 Jun 2011). 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 (Percent of All Base Plates With Leakage) (time frame: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day). 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 7 Oct 2011.