Stoma IleostomyNCT07316530
Clinical Investigation Exploring a Newly Developed Ostomy Baseplate.
A study testing CP381 in people with Stoma Ileostomy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, which affect their quality of life negatively. Among the main reasons for developing PSCs are that the peristomal skin is exposed to stomal output either due to leakage of output under the baseplate and/or imperfect… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Ileostomy
- What is being tested?
- CP381
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Nov 2025to 9 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Has given written informed consent
- Is at least 18 years old
- Has full legal capacity
- Has an ileostomy with consistent liquid faecal output (6-7 Bristol scale).
- Has used flat SenSura Mio 1-piece or 2-piece for at least 14 days before the inclusion.
- Has had the stoma for at least 90 days
Show all 12Show fewer
- Has a stoma size less than 45mm in diameter
- Has experienced symptoms of peristomal skin complications such as itching, burning, or pain in the peristomal area within the last 14 days
- Has suitable peristomal skin area (assessed by investigator) to participate in investigation
- Is willing to refrain from analgesics within 24 hours before the test days
- Is willing to refrain from antihistamine within 96 hours before the test days
- Is willing to refrain from steroid treatment within 24 hours before the test days
Who cannot join
- Is currently receiving or have within the past 60 days received radio-and/or chemotherapy.
- low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for other indications than cancer.
- Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray.
- Is breastfeeding
- Is pregnant based on urine pregnancy test.
- Has known hypersensitivity towards any of the devices used in the investigation.
- Participates in other clinical investigations. Exception: Participation in other Coloplast sponsored 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 protocol
Trial locations and contacts
1 site in 1 country.
About this study
Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, which affect their quality of life negatively.
Among the main reasons for developing PSCs are that the peristomal skin is exposed to stomal output either due to leakage of output under the baseplate and/or imperfect cutting of the hole in the baseplate, and incorrect application creating a gap between the hole in the baseplate and the stoma.
To seal this gap, Coloplast has developed a new ostomy baseplate and the aim of the investigation is to explore the investigational device 's ability to help protect the peristomal skin.
- Conditions
- Stoma Ileostomy
- Being tested
- CP381
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP381Device
All subjects will test the investigational device and the comparator for 6 hours during two different test days, with at least 14 days between the test days.
Before the application of the investigational device as well as comparator, the stoma will be measured by the test personal and the baseplate will be pre-cut too big, leaving an approximately 5 mm distance from the edge of the hole in the baseplate to the stoma. The baseplates will be unique to each subject.
| Study group | Role | What they receive |
|---|---|---|
| Investigational device | Experimental | 1 day treatment with investigational device Receives: Device: CP381 |
| Comparator | Active comparator | 1 day treatment with comparator Receives: Device: CP381 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum itching
Maximum itching score between hour 4-6 after application of the investigational device and the comparator (scale from 0-10)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start3 Nov 2025
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma IleostomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316530
- Sponsor's protocol ID
- CP381
- Status last verified
- Oct 2025
- First submitted
- 25 Nov 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Exploring a Newly Developed Ostomy Baseplate.
- ClinicalTrials.gov ID
- NCT07316530
- Acronym / sponsor ID
- CP381
- Conditions
- Stoma Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, which affect their quality of life negatively.
Among the main reasons for developing PSCs are that the peristomal skin is exposed to stomal output either due to leakage of output under the baseplate and/or imperfect cutting of the hole in the baseplate, and incorrect application creating a gap between the hole in the baseplate and the stoma.
To seal this gap, Coloplast has developed a new ostomy baseplate and the aim of the investigation is to explore the investigational device 's ability to help protect the peristomal skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational device | Experimental | Device: CP3811 day treatment with investigational device |
| Comparator | Active comparator | Device: CP3811 day treatment with comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Has given written informed consent
- Is at least 18 years old
- Has full legal capacity
- Has an ileostomy with consistent liquid faecal output (6-7 Bristol scale).
- Has used flat SenSura Mio 1-piece or 2-piece for at least 14 days before the inclusion.
Key exclusion criteria (7 listed)
- Is currently receiving or have within the past 60 days received radio-and/or chemotherapy.
- low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for other indications than cancer.
- Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray.
- Is breastfeeding
- Is pregnant based on urine pregnancy test.
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 |
|---|---|---|
| CP381All subjects will test the investigational device and the comparator for 6 hours during two different test days, with at least 14 days between the test days. Before the application of the investigational device as well as comparator, the stoma will be measured by the test personal and the baseplate will be pre-cut too big, leaving an approximately 5 mm distance from the edge of the hole in the baseplate to the stoma. The baseplates will be unique to each subject. | Device | Comparator, Investigational device |
Primary outcome
Maximum itching
Time frame: 6 hours
Maximum itching score between hour 4-6 after application of the investigational device and the comparator (scale from 0-10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CP381 in people with Stoma Ileostomy, 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 12 inclusion and 7 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 23 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum itching (time frame: 6 hours). 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 23 Jan 2026.