Ileostomy - StomaNCT01994876
Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
A study testing Coloplast Test 1 and Coloplast Test 2 in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Netherlands.
Trial summary
To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances 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 Test 1 and Coloplast Test 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Nov 2012
- 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
- Subjects must comply with the following criteria in order to participate in the investigation:
- Are at least 18 years of age and have full legal capacity
- Have had an ileostomy for at least 3 months
- Have used a convex ostomy appliance for the last month
- Have given written informed consent
- Have an ileostomy with a diameter of 33 mm or less
- Have experience leakage (seeping) under the baseplate at least two times over the last two weeks
Who cannot join
- Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
- Have a loop ostomy (also called double-barrel or ostomy with two outlets)
- Are pregnant or breastfeeding
- Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
- Currently receiving or have received, within the last month, systemic or local steroid treatment (adreno-cortical hormone) in the peristomal area
- Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin))
- Are currently participating in another clinical investigation or has previously participated in this investigation
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances
- Conditions
- Ileostomy - Stoma
- Being tested
- Coloplast Test 1, Coloplast Test 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast Test 1Device
Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance
Coloplast Test 2Device
Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance
| Study group | Role | What they receive |
|---|---|---|
| First Coloplast Test 1 | Experimental | The subjects first test their own product to collect a baseline measurement
The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2 Receives: Device: Coloplast Test 1; Device: Coloplast Test 2 |
| First Coloplast Test 2 | Experimental | The subjects first test their own product to collect baseline measurements
The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1 Receives: Device: Coloplast Test 1; Device: Coloplast Test 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Leakage
The degree of leakage was measured with a 32-point scale developed by Coloplast A/S, where 0 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)
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 posted26 Nov 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionNov 2012
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kalid S Abd-Elaziz, MD, Principal investigator, QPS Holdings LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994876
- Sponsor's protocol ID
- CP229
- Status last verified
- Feb 2014
- First submitted
- 1 Oct 2013
- Last updated
- 7 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
- ClinicalTrials.gov ID
- NCT01994876
- Acronym / sponsor ID
- CP229
- Conditions
- Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Posted 7 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Coloplast Test 1 | Experimental | Device: Coloplast Test 1, Device: Coloplast Test 2The subjects first test their own product to collect a baseline measurement The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2 |
| First Coloplast Test 2 | Experimental | Device: Coloplast Test 1, Device: Coloplast Test 2The subjects first test their own product to collect baseline measurements The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must comply with the following criteria in order to participate in the investigation:
- Are at least 18 years of age and have full legal capacity
- Have had an ileostomy for at least 3 months
- Have used a convex ostomy appliance for the last month
- Have given written informed consent
Key exclusion criteria (7 listed)
- Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
- Have a loop ostomy (also called double-barrel or ostomy with two outlets)
- Are pregnant or breastfeeding
- Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
- Currently receiving or have received, within the last month, systemic or local steroid treatment (adreno-cortical hormone) in the peristomal area
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 Test 1Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance | Device | First Coloplast Test 1, First Coloplast Test 2 |
| Coloplast Test 2Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance | Device | First Coloplast Test 1, First Coloplast Test 2 |
Primary outcome
Degree of Leakage
Time frame: 14 days
The degree of leakage was measured with a 32-point scale developed by Coloplast A/S, where 0 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kalid S Abd-Elaziz, MD principal investigator
QPS Holdings LLC
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 Test 1 and Coloplast Test 2 in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Netherlands.
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 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 7 Apr 2014. 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 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?
Yes. Results are posted in the registry (first posted 7 Apr 2014). 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?
Degree of Leakage (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 7 Apr 2014.