Ileostomy - StomaNCT01272869
Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
A study testing SenSura and Morfeus in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The aim of the current clinical investigation is to evaluate a new filter 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?
- SenSura and Morfeus
- 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
- Jan 2011to Mar 2011
- 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
- Be at least 18 years of age and have full legal capacity.
- Have given written informed consent.
- Be able to fill in the Case Report Form.
- Be ileostomy operated and have had a stoma for at least 6 months.
- Experience ballooning at least once per week.
- Be able to manage the bags themselves (application, removal).
- Be able to use a flat base plate.
- Have a stoma with a diameter less than 60 mm
Who cannot join
- Persons who irrigate
- Currently suffer from peristomal skin problems (i.e. bleeding or broken skin).
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- Pregnant or breastfeeding.
- Participate in other test at the same time.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the current clinical investigation is to evaluate a new filter
Read the detailed description
The filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.
- Conditions
- Ileostomy - Stoma
- Being tested
- SenSura, Morfeus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenSuraDevice
The ostomy bag filter will be tested for a period of 14 days
MorfeusDevice
The new ostomy bag filter will be tested for a period of 14 days
| Study group | Role | What they receive |
|---|---|---|
| Sensura | Active comparator | SenSura is the reference product and the product is already commercially available Receives: Device: SenSura |
| Morfeus | Experimental | The test product is the product with the proposed new filter (Morfeus) Receives: Device: Morfeus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.
Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.
Measured: Daily or at every change of bag in a period of a maximum of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2011
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
- 20 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
- NCT01272869
- Sponsor's protocol ID
- CP211OC
- Status last verified
- Nov 2012
- First submitted
- 14 Dec 2010
- Last updated
- 31 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
- ClinicalTrials.gov ID
- NCT01272869
- Acronym / sponsor ID
- CP211OC
- Conditions
- Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Posted 31 Dec 2012
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 clinical investigation is to evaluate a new filter
Detailed description
The filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensura | Active comparator | Device: SenSuraSenSura is the reference product and the product is already commercially available |
| Morfeus | Experimental | Device: MorfeusThe test product is the product with the proposed new filter (Morfeus) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be at least 18 years of age and have full legal capacity.
- Have given written informed consent.
- Be able to fill in the Case Report Form.
- Be ileostomy operated and have had a stoma for at least 6 months.
- Experience ballooning at least once per week.
Key exclusion criteria (5 listed)
- Persons who irrigate
- Currently suffer from peristomal skin problems (i.e. bleeding or broken skin).
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- Pregnant or breastfeeding.
- Participate in other test at the same time.
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 |
|---|---|---|
| SenSuraThe ostomy bag filter will be tested for a period of 14 days | Device | Sensura |
| MorfeusThe new ostomy bag filter will be tested for a period of 14 days | Device | Morfeus |
Primary outcome
Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.
Time frame: Daily or at every change of bag in a period of a maximum of 28 days
Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2012.
- 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 SenSura and Morfeus in people with Ileostomy - Stoma, 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 8 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 31 Dec 2012. 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 31 Dec 2012). 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?
Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period. (time frame: Daily or at every change of bag in a period of a maximum of 28 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 31 Dec 2012.