Ileostomy - StomaNCT03770078
Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
A study testing Test Product A in people with Ileostomy - Stoma and Colostomy Stoma, run by Coloplast A/S at 4 sites in 2 countries.
Trial summary
The study investigates the performance of a new adhesive with regard to the skin condition Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy - Stoma, Colostomy Stoma
- What is being tested?
- Test Product A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 12 Nov 2018to 6 Mar 2019
- 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
- Have an ileostomy or a colostomy with liquid* output (as their usual output)
- Be at least 18 years of age and have full legal capacity
- Have had their stoma for at least three months
- Be able to use products with max cut size 45 mm
- Have self-reported problems with leakage** (three times within 14 days)
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- Handle the Clinical App, test product and comparator product themselves
- Use a flat SenSura® Mio or a flat SenSura® with standard adhesive as their current product
- Minimum change of baseplate at least once every 3rd day
- Are willing and suitable (determined by investigator/study nurse) to use the test product and comparator without using a paste/mouldable ring during the investigation
- Are willing and suitable (determined by investigator/study nurse) to use a 1-piece product during the investigation
Who cannot join
- Are currently receiving or have within the past two months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
- Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (e.g. lotion or spray) or systemic treatment* (e.g. injection or tablets).
- Get a positive result of a pregnancy test for women of childbearing age/fertile (**clarified in section 6.3.2)
- Are breast feeding
- Are participating in other interventional clinical investigations or have previously participated in this investigation
- Exception:
- Participation in other Coloplast in-house clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP300) protocol.
- Have known hypersensitivity towards any of the products used in the investigation
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Denmark3 sites
CCBR Aalborg
Aalborg, 9000
Coloplast
Humlebæk, 3050
CCBR Vejle
Vejle, 7100
About this study
The study investigates the performance of a new adhesive with regard to the skin condition
- Conditions
- Ileostomy - Stoma, Colostomy Stoma
- Being tested
- Test Product A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Product ADevice
The test product is a newly developed ostomy product
| Study group | Role | What they receive |
|---|---|---|
| Study period | Experimental | First the subjects will use the comparator (SenSura Mio) and then the test products (Test Product A) Receives: Device: Test Product A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans Epidermal Water Loss
Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage.
Trans Epidermal Water Loss is reported in grams of water per square meter per hour (g/m^2/h).
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start12 Nov 2018
- Primary completion6 Mar 2019
- Study completion6 Mar 2019
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Birte P Jakobsen, MD, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770078
- Sponsor's protocol ID
- CP300
- Status last verified
- Mar 2025
- First submitted
- 7 Dec 2018
- Last updated
- 1 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
- ClinicalTrials.gov ID
- NCT03770078
- Acronym / sponsor ID
- CP300
- Conditions
- Ileostomy - Stoma, Colostomy Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Posted 1 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates the performance of a new adhesive with regard to the skin condition
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study period | Experimental | Device: Test Product AFirst the subjects will use the comparator (SenSura Mio) and then the test products (Test Product A) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have given written informed consent
- Have an ileostomy or a colostomy with liquid* output (as their usual output)
- Be at least 18 years of age and have full legal capacity
- Have had their stoma for at least three months
- Be able to use products with max cut size 45 mm
Key exclusion criteria (8 listed)
- Are currently receiving or have within the past two months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
- Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (e.g. lotion or spray) or systemic treatment* (e.g. injection or tablets).
- Get a positive result of a pregnancy test for women of childbearing age/fertile (**clarified in section 6.3.2)
- Are breast feeding
- Are 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 |
|---|---|---|
| Test Product AThe test product is a newly developed ostomy product | Device | Study period |
Primary outcome
Trans Epidermal Water Loss
Time frame: Four weeks
Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage. Trans Epidermal Water Loss is reported in grams of water per square meter per hour (g/m^2/h).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- 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.
Birte P Jakobsen, MD principal investigator
Consultant
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Product A in people with Ileostomy - Stoma and Colostomy Stoma, run by Coloplast A/S at 4 sites in 2 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 11 inclusion and 8 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 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Sweden. 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 1 Apr 2025). 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?
Trans Epidermal Water Loss (time frame: Four 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 1 Apr 2025.