Ileostomy - StomaNCT02517541
A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
A study testing SenSura Mio Convex Soft in people with Ileostomy - Stoma and Colostomy, run by Coloplast A/S at 9 sites in 4 countries.
Trial summary
The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy - Stoma, Colostomy
- What is being tested?
- SenSura Mio Convex Soft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Sep 2015to Mar 2016
- 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
- Have an ileostomy or colostomy
- Have had their ostomy for at least 3 months
- Must use 1 piece open or closed ostomy products during the test period
- Currently using a 1 piece. flat product
Show all 10Show fewer
- Must be able to use custom cut product
- Have intact peristomal skin
- Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
- Are evaluated to be suitable for a soft convex product
Who cannot join
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- Currently or having within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- Are pregnant or breastfeeding
- Participating in other interventional clinical investigations or have previously participated in this investigation
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United Kingdom5 sites
Synexus Midlands
Birmingham, B15 2SQ
Pilgrim Hospital
Boston
Cheltenham General Hospital
Cheltenham, G1537AN
Kettering General hospital
Kettering, NN168UZ
Lincon Country hospital
Lincoln, LN25QY
United States2 sites
University of Chicago Medicine
Chicago, Illinois, 60637
Prism research center
Saint Paul, Minnesota, 55114
About this study
The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.
Read the detailed description
72 subjects will be included. Each subject will attend 3 visits at the clinic/hospital or at the subjects home depending on the final site set-up. Each subject will be enrolled for 14 weeks in total for the entire investigation.
Coloplast will provide SenSura Mio Convex Soft for all subjects via the investigator. Based on the subjects' usual changing pattern, the investigator will provide the subjects with enough products for the whole test period.
The subject will answer questions regarding the tested products by filling out the subject part in the eCRF daily. The subject will answer questions using an electronic device and use the device to take pictures of the peristomal skin and used products at each product change. The Investigator fills out the investigator part of the eCRF at each visit. The subjects must complete the general questions at the end of each test period before their second and third visit at the Clinic/hospital or at home to avoid influence by the investigator.
The use of accessories will be noted in the eCRF. Samples of biological material will not be taken or used in this investigation. Patient files from own physician will not be used for subjects recruited via a Coloplast's database. The investigators may use patient files for subjects recruited via hospital sites/ostomy clinics to identifying relevant subjects and/or to verify baseline information, concomitant medication or adverse events. To be able to fulfil the objectives, the investigation must include both ileostomists and colostomists.
- Conditions
- Ileostomy - Stoma, Colostomy
- Being tested
- SenSura Mio Convex Soft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenSura Mio Convex SoftDevice
SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast
| Study group | Role | What they receive |
|---|---|---|
| Test period | Experimental | The arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft) Receives: Device: SenSura Mio Convex Soft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage Under the Baseplate (cm^2)
The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area.
Measured: 14 weeks (2 weeks baseline + 12 weeks intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Camilla F Vibjerg, M.Sc.pharm, Study chair, Head of Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517541
- Sponsor's protocol ID
- CP259
- Status last verified
- Nov 2022
- First submitted
- 5 Aug 2015
- Last updated
- 16 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
- ClinicalTrials.gov ID
- NCT02517541
- Acronym / sponsor ID
- CP259
- Conditions
- Ileostomy - Stoma, Colostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Posted 6 Sep 2018
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 study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.
Detailed description
72 subjects will be included. Each subject will attend 3 visits at the clinic/hospital or at the subjects home depending on the final site set-up. Each subject will be enrolled for 14 weeks in total for the entire investigation.
Coloplast will provide SenSura Mio Convex Soft for all subjects via the investigator. Based on the subjects' usual changing pattern, the investigator will provide the subjects with enough products for the whole test period.
The subject will answer questions regarding the tested products by filling out the subject part in the eCRF daily. The subject will answer questions using an electronic device and use the device to take pictures of the peristomal skin and used products at each product change. The Investigator fills out the investigator part of the eCRF at each visit. The subjects must complete the general questions at the end of each test period before their second and third visit at the Clinic/hospital or at home to avoid influence by the investigator.
The use of accessories will be noted in the eCRF. Samples of biological material will not be taken or used in this investigation. Patient files from own physician will not be used for subjects recruited via a Coloplast's database. The investigators may use patient files for subjects recruited via hospital sites/ostomy clinics to identifying relevant subjects and/or to verify baseline information, concomitant medication or adverse events. To be able to fulfil the objectives, the investigation must include both ileostomists and colostomists.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test period | Experimental | Device: SenSura Mio Convex SoftThe arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft) |
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
- Have an ileostomy or colostomy
- Have had their ostomy for at least 3 months
- Must use 1 piece open or closed ostomy products during the test period
Key exclusion criteria (4 listed)
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- Currently or having within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- 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 Mio Convex SoftSenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast | Device | Test period |
Primary outcome
Leakage Under the Baseplate (cm^2)
Time frame: 14 weeks (2 weeks baseline + 12 weeks intervention)
The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- 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.
Camilla F Vibjerg, M.Sc.pharm study chair
Head of Clinical Operations
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SenSura Mio Convex Soft in people with Ileostomy - Stoma and Colostomy, run by Coloplast A/S at 9 sites in 4 countries.
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 4 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 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, United States, Netherlands, Norway. 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 6 Sep 2018). 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 Baseplate (cm^2) (time frame: 14 weeks (2 weeks baseline + 12 weeks intervention)). 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 16 Nov 2022.