Ileostomy - StomaNCT03154944
A Clinical Investigation Evaluating Three New 1-piece Ostomy Products
A study testing Ostomy device 1, Ostomy device 2 and Ostomy device 3 in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Denmark.
Trial summary
This investigation evaluates three new ostomy appliances and their impact on the peristomal skin. 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?
- Ostomy device 1, Ostomy device 2 and Ostomy device 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2017to 2 Feb 2018
- 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 and in DK: signed a letter of authority
- Be at least 18 years of age and have full legal capacity
- Have had their ileostomy for at least 3 months
- Have an ileostomy with a diameter between 10 and 55 mm
- Be able to handle the Clinical App. and product themselves
- Must be able to use custom cut product
Show all 10Show fewer
- Minimum change of product every second day
- If current product is SenSura Mio - Be willing to use Maxi bag during investigation
- Subject using Sensura or Sensura Mio flat 1 pc. open for at least two weeks before inclusion in the study.
- Negative result of a pregnancy test for women of childbearing age (only DK)
Who cannot join
- Are currently receiving or have within the past 2 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. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
- Are pregnant or breastfeeding**
- Are participating in other interventional clinical investigations or have previously participated in this investigation
- Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
- Have known hypersensitivity towards any of the products used in the investigation
Trial locations and contacts
1 site in 1 country.
About this study
This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.
- Conditions
- Ileostomy - Stoma
- Being tested
- Ostomy device 1, Ostomy device 2, Ostomy device 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostomy device 1Device
This device consists of a known adhesive and a new top film
Ostomy device 2Device
This device consists of a new adhesive and a known top film
Ostomy device 3Device
This device consists of a known adhesive and a new top film
| Study group | Role | What they receive |
|---|---|---|
| Ostomy device 1 | Experimental | In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film Receives: Device: Ostomy device 1 |
| Ostomy device 2 | Experimental | In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film Receives: Device: Ostomy device 2 |
| Ostomy device 3 | Experimental | In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film Receives: Device: Ostomy device 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans Epidermal Water Loss
The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. Measurements are in grams of water per square meter per hour (g/m^2/h).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start15 May 2017
- Primary completion2 Feb 2018
- Study completion2 Feb 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Birte P Jakosen, MD, Principal investigator, Medial director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154944
- Sponsor's protocol ID
- CP275
- Status last verified
- Mar 2025
- First submitted
- 15 May 2017
- Last updated
- 28 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation Evaluating Three New 1-piece Ostomy Products
- ClinicalTrials.gov ID
- NCT03154944
- Acronym / sponsor ID
- CP275
- Conditions
- Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Posted 28 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ostomy device 1 | Experimental | Device: Ostomy device 1In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film |
| Ostomy device 2 | Experimental | Device: Ostomy device 2In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film |
| Ostomy device 3 | Experimental | Device: Ostomy device 3In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film |
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 and in DK: signed a letter of authority
- Be at least 18 years of age and have full legal capacity
- Have had their ileostomy for at least 3 months
- Have an ileostomy with a diameter between 10 and 55 mm
- Be able to handle the Clinical App. and product themselves
Key exclusion criteria (6 listed)
- Are currently receiving or have within the past 2 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. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
- Are pregnant or breastfeeding**
- Are participating in other interventional clinical investigations or have previously participated in this investigation
- Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
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 |
|---|---|---|
| Ostomy device 1This device consists of a known adhesive and a new top film | Device | Ostomy device 1 |
| Ostomy device 2This device consists of a new adhesive and a known top film | Device | Ostomy device 2 |
| Ostomy device 3This device consists of a known adhesive and a new top film | Device | Ostomy device 3 |
Primary outcome
Trans Epidermal Water Loss
Time frame: 7 days
The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. Measurements are 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 28 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Jakosen, MD principal investigator
Medial director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ostomy device 1, Ostomy device 2 and Ostomy device 3 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 10 inclusion and 6 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 28 Mar 2025. 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 28 Mar 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: 7 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 28 Mar 2025.