Subjects With an IleostomyNCT01800890
Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
A study testing Coloplast A, Coloplast B and Coloplast C in people with Subjects With an Ileostomy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjects With an Ileostomy
- What is being tested?
- Coloplast A, Coloplast B and Coloplast C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Apr 2013
- 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 signed letter of authority form.
- Be at least 18 years of age and have full legal capacity.
- Be able to handle the appliances themselves
- Have an ileostomy with a diameter between 15 and 40 mm.
- Have had their ostomy for at least three months.
- Use minimum 1 baseplate every third day.
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- Currently use 2-piece flat mechanical coupling product with open bag and a coupling size in the inter val of 43-55mm (both extremes included)
- Must be able to use custom cut product
- Accept to test three 2-piece products within the study.
- Negative result of a pregnancy test for women of childbearing age.
Who cannot join
- Use irrigation during the study (flush the stoma with water).
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
- Are pregnant or breastfeeding.
- Participating in other interventional clinical investigations or have previously participated in this investigation.
- More than three days wear time as usual change pattern.
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- Currently using ostomy belt
- Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive)
- Have a loop ileostomy
- Known hypersensitivity towards any of the test products
- Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
Read the detailed description
The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.
- Conditions
- Subjects With an Ileostomy
- Being tested
- Coloplast A, Coloplast B, Coloplast C, SenSura Click
- Keywords
- stoma ileostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast ADevice
Coloplast A is a newly developed 2-piece ostomy appliance
Coloplast BDevice
Coloplast B is a newly developed 2-piece ostomy appliance
Coloplast CDevice
Coloplast C is a newly developed 2-piece ostomy appliance
SenSura ClickDevice
The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1 | Other | Subjects randomised to Treatment sequence 1 will test three different products:
1. Coloplast A
2. Coloplast B
3. SenSura Click
The subjects test the three test products in a randomized order: ABS; BSA, SAB Receives: Device: Coloplast A; Device: Coloplast B; Device: SenSura Click |
| Treatment sequence 2 | Experimental | Subjects randomised to Treatment sequence 2 will test three different products:
1. Coloplast C (C)
2. Coloplast B (B)
3. SenSura Click (S)
The subjects test the three test products in a randomized order: CBS; BSC, SCB Receives: Device: Coloplast B; Device: Coloplast C; Device: SenSura Click |
| Treatment sequence 3 | Experimental | Subjects randomised to Treatment sequence 3 will test three different products:
1. Coloplast A (A)
2. Coloplast C (C)
3. SenSura Click (S)
The subjects test the three test products in a randomized order: ACS; CSA, SAC Receives: Device: Coloplast A; Device: Coloplast C; Device: SenSura Click |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Leakage
The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S.
The 4-point leakage scale has four choices
- No leakage
- Starting to leakage
- Leakage
- Sudden leakage
Leakage was assessed at every baseplate change
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
- Study completionApr 2013
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 Subjects With an 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Carter, MSc, Study chair, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800890
- Sponsor's protocol ID
- CP234
- Status last verified
- Jul 2014
- First submitted
- 22 Feb 2013
- Last updated
- 6 Aug 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 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
- ClinicalTrials.gov ID
- NCT01800890
- Acronym / sponsor ID
- CP234
- Conditions
- Subjects With an Ileostomy
- Keywords
- stoma ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Posted 6 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
Detailed description
The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1 | Other | Device: Coloplast A, Device: Coloplast B, Device: SenSura ClickSubjects randomised to Treatment sequence 1 will test three different products: 1. Coloplast A 2. Coloplast B 3. SenSura Click The subjects test the three test products in a randomized order: ABS; BSA, SAB |
| Treatment sequence 2 | Experimental | Device: Coloplast B, Device: Coloplast C, Device: SenSura ClickSubjects randomised to Treatment sequence 2 will test three different products: 1. Coloplast C (C) 2. Coloplast B (B) 3. SenSura Click (S) The subjects test the three test products in a randomized order: CBS; BSC, SCB |
| Treatment sequence 3 | Experimental | Device: Coloplast A, Device: Coloplast C, Device: SenSura ClickSubjects randomised to Treatment sequence 3 will test three different products: 1. Coloplast A (A) 2. Coloplast C (C) 3. SenSura Click (S) The subjects test the three test products in a randomized order: ACS; CSA, SAC |
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 signed letter of authority form.
- Be at least 18 years of age and have full legal capacity.
- Be able to handle the appliances themselves
- Have an ileostomy with a diameter between 15 and 40 mm.
- Have had their ostomy for at least three months.
Key exclusion criteria (11 listed)
- Use irrigation during the study (flush the stoma with water).
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
- Are pregnant or breastfeeding.
- Participating in other interventional clinical investigations or have previously participated in this investigation.
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 AColoplast A is a newly developed 2-piece ostomy appliance | Device | Treatment sequence 1, Treatment sequence 3 |
| Coloplast BColoplast B is a newly developed 2-piece ostomy appliance | Device | Treatment sequence 1, Treatment sequence 2 |
| Coloplast CColoplast C is a newly developed 2-piece ostomy appliance | Device | Treatment sequence 2, Treatment sequence 3 |
| SenSura ClickThe comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S. | Device | Treatment sequence 1, Treatment sequence 2, Treatment sequence 3 |
Primary outcome
Degree of Leakage
Time frame: 10 days
The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S. The 4-point leakage scale has four choices 1. No leakage 2. Starting to leakage 3. Leakage 4. Sudden leakage Leakage was assessed at every baseplate change
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Daniel Carter, MSc study chair
Coloplast A/S
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 A, Coloplast B and Coloplast C in people with Subjects With an 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 10 inclusion and 11 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 Aug 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 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 6 Aug 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: 10 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 Aug 2014.