Ileostomy - StomaNCT03439241
Assessment of the Performance of a New Ostomy Device in Subjects Having an Ileostomy
A study testing Coloplast ostomy device in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The purpose was to investigate the performance of a new ostomy device measured with a measuring device. 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?
- Coloplast ostomy device
- 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
- 5 Feb 2018to 16 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
- Can use a product with max cut size 45 mm
- Self-reported problems with leakage (3 x within 14 days)
- Be willing and suitable (determined by the investigator representative) to use the test product without using a paste/mouldable ring during the test period
Show all 9Show fewer
- Must be able to use custom cut product
- Minimum change of product every third day
- 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 is 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 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 (CP278) 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
1 site in 1 country.
About this study
Official title: Assessment of the Performance of a New Ostomy Device in Sub-jects Having an Ileostomy
The purpose was to investigate the performance of a new ostomy device measured with a measuring device.
- Conditions
- Ileostomy - Stoma
- Being tested
- Coloplast ostomy device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast ostomy deviceDevice
the test product is a newly developed Coloplast ostomy device
| Study group | Role | What they receive |
|---|---|---|
| Silent arm | Experimental | The participants test the new Coloplast ostomy device use the product as they usually would. Receives: Device: Coloplast ostomy device |
| Active arm | Experimental | The participants test the tnew Coloplast ostomy device and are guided by the measuring device Receives: Device: Coloplast ostomy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
wear time (hours)
Wear time is recorded at each baseplate change
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 posted20 Feb 2018
- Study start5 Feb 2018
- Primary completion16 Apr 2018
- Study completion16 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
- Parallel groups
- Model description
- The trial starts with a baseline period. After 4 baseplate changes the subjects is randomised into two arms.
- 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
- Investigators
- Birte P Jakobsen, MD, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439241
- Sponsor's protocol ID
- CP278
- Status last verified
- Jun 2018
- First submitted
- 12 Feb 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 the Performance of a New Ostomy Device in Sub-jects Having an Ileostomy
- ClinicalTrials.gov ID
- NCT03439241
- Acronym / sponsor ID
- CP278
- Conditions
- Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 20 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 purpose was to investigate the performance of a new ostomy device measured with a measuring device.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial starts with a baseline period. After 4 baseplate changes the subjects is randomised into two arms.
| Arm | Type | Receives |
|---|---|---|
| Silent arm | Experimental | Device: Coloplast ostomy deviceThe participants test the new Coloplast ostomy device use the product as they usually would. |
| Active arm | Experimental | Device: Coloplast ostomy deviceThe participants test the tnew Coloplast ostomy device and are guided by the measuring device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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
- Can use a product with max cut size 45 mm
- Self-reported problems with leakage (3 x within 14 days)
Key exclusion criteria (6 listed)
- Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy is 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 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 (CP278) 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 |
|---|---|---|
| Coloplast ostomy devicethe test product is a newly developed Coloplast ostomy device | Device | Active arm, Silent arm |
Primary outcome
wear time (hours)
Time frame: 14 days
Wear time is recorded at each baseplate change
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coloplast ostomy device 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 9 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 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?
wear time (hours) (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.