Stoma ColostomyPhase 4NCT01513330
Performance Study of Newly Developed Ostomy Products
A Phase 4 study testing SenSura Mio in people with Stoma Colostomy, run by Coloplast A/S at 1 site in Germany.
Trial summary
The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Colostomy
- What is being tested?
- SenSura Mio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Aug 2012
- Phase
- Phase 4
- 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.
- Have experienced leakage under the base plate at least once a week over the last two weeks.
- Be able to handle the bags themselves or with help from caregiver (e.g. spouse).
- Have a colostomy with a diameter between 20 and 45 mm.
- Have had their ostomy for at least three months.
Show all 9Show fewer
- Currently use a 1-piece flat product with closed bag.
- Use minimum 1 product per day.
- Be suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator).
Who cannot join
- Use irrigation during the study (flush the stoma with water).
- Currently receiving or have within the past 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.
- Are pregnant or breastfeeding.
- Participating in other interventional clinical investigations or have previously participated in this investigation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-labelled, Randomised, Controlled, Crossover Investigation Evaluating Performance of a Newly Developed Ostomy Care Product Compared to Standard Care.
The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.
- Conditions
- Stoma Colostomy
- Being tested
- SenSura Mio, Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenSura MioDevice
Ostomy product - 1 piece closed bag
Standard CareDevice
Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
| Study group | Role | What they receive |
|---|---|---|
| First Standard Care, then SenSura Mio | Experimental | Subjects first test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) and after cross-over SenSura Mio Receives: Device: SenSura Mio; Device: Standard Care |
| First SenSura Mio, then Standard Care | Experimental | Subjects first test SenSura Mio and after cross-over Standard Care(Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) Receives: Device: SenSura Mio; Device: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)
Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionAug 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 Stoma 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenche Sundberg, stoma nurse, Principal investigator, Diakonhjemmet Sykhus, OsloMerete Bjørke, Stoma Nurse, Principal investigator, St. Olavs HopsitalVigids Dagsland, Stoma Nurse, Principal investigator, Haugesund SykhusRandi Melum, Stoma Nurse, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513330
- Sponsor's protocol ID
- CP219
- Status last verified
- Nov 2013
- First submitted
- 10 Jan 2012
- Last updated
- 9 Jan 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 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labelled, Randomised, Controlled, Crossover Investigation Evaluating Performance of a Newly Developed Ostomy Care Product Compared to Standard Care.
- ClinicalTrials.gov ID
- NCT01513330
- Acronym / sponsor ID
- CP219
- Conditions
- Stoma Colostomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Posted 9 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Standard Care, then SenSura Mio | Experimental | Device: SenSura Mio, Device: Standard CareSubjects first test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) and after cross-over SenSura Mio |
| First SenSura Mio, then Standard Care | Experimental | Device: SenSura Mio, Device: Standard CareSubjects first test SenSura Mio and after cross-over Standard Care(Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have given written informed consent.
- Be at least 18 years of age and have full legal capacity.
- Have experienced leakage under the base plate at least once a week over the last two weeks.
- Be able to handle the bags themselves or with help from caregiver (e.g. spouse).
- Have a colostomy with a diameter between 20 and 45 mm.
Key exclusion criteria (5 listed)
- Use irrigation during the study (flush the stoma with water).
- Currently receiving or have within the past 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.
- 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 |
|---|---|---|
| SenSura MioOstomy product - 1 piece closed bag | Device | First SenSura Mio, then Standard Care, First Standard Care, then SenSura Mio |
| Standard CareOstomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima. | Device | First SenSura Mio, then Standard Care, First Standard Care, then SenSura Mio |
Primary outcome
Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)
Time frame: 14 days
Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 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.
Wenche Sundberg, stoma nurse principal investigator
Diakonhjemmet Sykhus, Oslo
Merete Bjørke, Stoma Nurse principal investigator
St. Olavs Hopsital
Vigids Dagsland, Stoma Nurse principal investigator
Haugesund Sykhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SenSura Mio in people with Stoma Colostomy, run by Coloplast A/S at 1 site in Germany.
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 9 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 9 Jan 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Jan 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?
Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage) (time frame: 14 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 9 Jan 2014.