Ileostomy - StomaNCT03427203
Assessment of New Ostomy Devices in Subjects Having an Ileostomy
A study testing SenSura Mio, Coloplast Ostomy device 1 and Coloplast Ostomy device in people with Ileostomy - Stoma, run by Coloplast A/S at 3 sites in 2 countries.
Trial summary
The study investigates the performance of three new adhesives with regard to leakage and the skin condition. 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?
- SenSura Mio, Coloplast Ostomy device 1 and Coloplast Ostomy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 9 Jan 2018to 6 Apr 2018
- 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
- 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
- Must be able to use custom cut product
- Can use a product with max cut size 45 mm
- Self-reported problems with leakage (3 x within 14 days)
- Get a 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 4.1. Exception: Participation in other Coloplast in-house clinical investigations are 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 (CP264) protocol.
- 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
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: Assessment of New Enhanced Ostomy Devices in Real-life Set-tings in Subjects Having an Ileostomy
The study investigates the performance of three new adhesives with regard to leakage and the skin condition.
- Conditions
- Ileostomy - Stoma
- Being tested
- SenSura Mio, Coloplast Ostomy device 1, Coloplast Ostomy device, Coloplast Ostomy device 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenSura MioDevice
SenSura Mio is a marked ostomy device which is used as the comparator in this study
Coloplast Ostomy device 1Device
Coloplast Ostomy device 1 a newly developed ostomy device
Coloplast Ostomy deviceDevice
Coloplast Ostomy device 2 a newly developed ostomy device
Coloplast Ostomy device 3Device
Coloplast Ostomy device 3 a newly developed ostomy device
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | The subjects test the products in the following order
SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3 Receives: Device: SenSura Mio; Device: Coloplast Ostomy device 1; Device: Coloplast Ostomy device; Device: Coloplast Ostomy device 3 |
| Arm 2 | Experimental | The subjects test the products in the following order
SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2 Receives: Device: SenSura Mio; Device: Coloplast Ostomy device 1; Device: Coloplast Ostomy device; Device: Coloplast Ostomy device 3 |
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 aloss 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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start9 Jan 2018
- Primary completion6 Apr 2018
- Study completion6 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 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, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427203
- Sponsor's protocol ID
- CP264
- Status last verified
- Jun 2018
- First submitted
- 29 Jan 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- 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 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of New Enhanced Ostomy Devices in Real-life Set-tings in Subjects Having an Ileostomy
- ClinicalTrials.gov ID
- NCT03427203
- Acronym / sponsor ID
- CP264
- Conditions
- Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 9 Feb 2018 (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.
The study investigates the performance of three new adhesives with regard to leakage and the skin condition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: SenSura Mio, Device: Coloplast Ostomy device 1, Device: Coloplast Ostomy device, Device: Coloplast Ostomy device 3The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3 |
| Arm 2 | Experimental | Device: SenSura Mio, Device: Coloplast Ostomy device 1, Device: Coloplast Ostomy device, Device: Coloplast Ostomy device 3The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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
- Must be able to use custom cut product
- Can use a product with max cut size 45 mm
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 4.1. Exception: Participation in other Coloplast in-house clinical investigations are 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 (CP264) protocol.
- 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 |
|---|---|---|
| SenSura MioSenSura Mio is a marked ostomy device which is used as the comparator in this study | Device | Arm 1, Arm 2 |
| Coloplast Ostomy device 1Coloplast Ostomy device 1 a newly developed ostomy device | Device | Arm 1, Arm 2 |
| Coloplast Ostomy deviceColoplast Ostomy device 2 a newly developed ostomy device | Device | Arm 1, Arm 2 |
| Coloplast Ostomy device 3Coloplast Ostomy device 3 a newly developed ostomy device | Device | Arm 1, Arm 2 |
Primary outcome
Trans epidermal water loss
Time frame: 14 days
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 aloss 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
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 6 Jun 2018.
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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
Medical Director
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SenSura Mio, Coloplast Ostomy device 1 and Coloplast Ostomy device in people with Ileostomy - Stoma, run by Coloplast A/S at 3 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 7 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Netherlands. 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?
Trans epidermal water loss (time frame: 14 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 6 Jun 2018.