Stoma IleostomyNCT07376421
Clinical Investigation Exploring a Newly Developed Ostomy Baseplate
A study testing Incestigational device and Comparator 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?
- Incestigational device and Comparator
- 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
- 24 Jan 2026to 9 Apr 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 consent
- Is at least 18 years of age
- Has full legal capacity
- Has an ileostomy with consistent liquid fecal output (6-7 Bristol scale).
- Has used flat 1- or 2-piece SenSura Mio, SenSura or Assura Coloplast products for at least 14 days prior to inclusion.
- Has had the stoma for at least 90 days.
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- Has a stoma size less than 40mm in diameter
- Has experienced leakage under the baseplate at least three times within the last 14 days.
- Leakage defined as output/seeping under the baseplate (see Appendix A)
- 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)
- Is able to handle the electronic diary (questionnaire/photo) themselves. If needed, a trained spouse or caretaker is allowed to assist.
- Is able to handle (apply, remove, etc.) the investigational devices themselves.
- Understands that any supporting products under the baseplate are not permissible during the investigation (except for adhesive removers) and is willing to not use these during the investigation.
- Is willing and suitable (determined by the Principal Investigator or designee) to use a flat 2-piece device during the investigation.
- Is willing to change the baseplate at least every third/fourth day during the investigation.
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 treatment.
- Is breastfeeding.
- Is pregnant based on urine pregnancy test.
- Has known hypersensitivity towards any of the investigational devices used in the investigation.
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- Has a complicated stoma at baseline, as assessed by investigator (e.g., dehiscence/prolapse/hernia).
- 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 is otherwise complying with the inclusion and exclusion criteria of this protocol.
- Daily use of analgesics, antihistamine or steroid treatment
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
- Incestigational device, Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incestigational deviceDevice
4 weeks treatment with investigational device
ComparatorDevice
4 weeks treatment with comparator
| Study group | Role | What they receive |
|---|---|---|
| Investigational device | Experimental | 4 weeks treatment with investigational device Receives: Device: Incestigational device |
| Comparator | Active comparator | 4 weeks treatment with investigational device Receives: Device: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum itching scale 0-10)
Itching score (weekly max at steady state* scale 0-10).
- To account for a possible carry-over effect, the steady state period of the treatment period begins after two weeks of investigational device or comparator use. It is anticipated that the skin will have adapted to the new device after two weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start24 Jan 2026
- Primary completion9 Apr 2026
- Study completion9 Apr 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
- 20 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
- NCT07376421
- Sponsor's protocol ID
- CP383
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 1 May 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 1 May 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
- NCT07376421
- Acronym / sponsor ID
- CP383
- Conditions
- Stoma Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2026 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 29 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: Incestigational device4 weeks treatment with investigational device |
| Comparator | Active comparator | Device: Comparator4 weeks treatment with investigational device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Has given written consent
- Is at least 18 years of age
- Has full legal capacity
- Has an ileostomy with consistent liquid fecal output (6-7 Bristol scale).
- Has used flat 1- or 2-piece SenSura Mio, SenSura or Assura Coloplast products for at least 14 days prior to inclusion.
Key exclusion criteria (9 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 treatment.
- 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 |
|---|---|---|
| Incestigational device4 weeks treatment with investigational device | Device | Investigational device |
| Comparator4 weeks treatment with comparator | Device | Comparator |
Primary outcome
Maximum itching scale 0-10)
Time frame: 8 weeks
Itching score (weekly max at steady state* scale 0-10). * To account for a possible carry-over effect, the steady state period of the treatment period begins after two weeks of investigational device or comparator use. It is anticipated that the skin will have adapted to the new device after two weeks.
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 1 May 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 Incestigational device and Comparator 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 16 inclusion and 9 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 May 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 scale 0-10) (time frame: 8 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 May 2026.