Ileostomy - StomaNCT01957488
Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece
A study testing Coloplast Test Product 1, Coloplast Test Product 2 and Coloplast SenSura in people with Ileostomy - Stoma, run by Coloplast A/S at 4 sites in 4 countries.
Trial summary
The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products 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 Product 1, Coloplast Test Product 2 and Coloplast SenSura
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2013to Sep 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 (mandatory in DK)
- Be at least 18 years of age and have full legal capacity.
- Be able to handle the products themselves
- Have an ileostomy with a diameter between 10 and 40 mm.
- Have had their ostomy for at least three months.
- Have within the last month used a 1-piece flat product with open bag
Show all 11Show fewer
- Currently using midi or maxi bags
- Willing to use minimum 1 product every second day, i.e. maximum 2 days wear time.
- Be suitable for participation in the investigation
- Must be able to use custom cut product
- Negative result of a pregnancy test for women of childbearing age (only DK)
Who cannot join
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area
- Are pregnant or breastfeeding
- Participating in other interventional clinical investigations or have previously participated in this investigation
- Has participated in the previous explorative Coloplast studies CP236 and CP237
- Are currently or during the study using ostomy belt
Show all 9Show fewer
- Has a stoma below skin surface
- Currently suffering from peristomal skin problems (i.e.bleeding and/or broken skin)
- Has known hypersensitivity towards any of the test products
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Investigating the Safety and Performance of Two New 1-piece Ostomy Products in 180 Subjects With Ileostomy
The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products
Read the detailed description
The present investigation aims at testing the performance and safety of the two new 1-piece ostomy products
- Conditions
- Ileostomy - Stoma
- Being tested
- Coloplast Test Product 1, Coloplast Test Product 2, Coloplast SenSura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast Test Product 1Device
Coloplast Test product 1 is a newly developed 1-piece ostomy appliance
Coloplast Test Product 2Device
Coloplast Test product 2 is a newly developed 1-piece ostomy appliance
Coloplast SenSuraDevice
Also called SenSura 1-piece
SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1; First Coloplast Test product 1 | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects are first allocated to test Coloplast Test product 1 and secondly test either:
1. Coloplast Test product 1 and thereafter Coloplast SenSura
2. Coloplast Sensura and thereafter Coloplast Test product 2 Receives: Device: Coloplast Test Product 1; Device: Coloplast Test Product 2; Device: Coloplast SenSura |
| Treatment seqence 2; First Coloplast Test product 2. | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects are first allocated to test Coloplast Test product 2 and secondly test either:
1. Coloplast Test product 1 and thereafter Coloplast SenSura
2. Coloplast Sensura and thereafter Coloplast Test product 1 Receives: Device: Coloplast Test Product 1; Device: Coloplast Test Product 2; Device: Coloplast SenSura |
| Treatment sequence 3, First Coloplast SenSura | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects are first allocated to test Coloplast SenSura and secondly test either:
1. Coloplast Test product 2 and thereafter Coloplast Test product 1
2. Coloplast Test product 1 and thereafter Coloplast Test product 2 Receives: Device: Coloplast Test Product 1; Device: Coloplast Test Product 2; Device: Coloplast SenSura |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage
The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
Measured: 14 +- 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionSep 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 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
- 183 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, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957488
- Sponsor's protocol ID
- CP242
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2013
- Last updated
- 10 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Safety and Performance of Two New 1-piece Ostomy Products in 180 Subjects With Ileostomy
- ClinicalTrials.gov ID
- NCT01957488
- Acronym / sponsor ID
- CP242
- Conditions
- Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 17 Sep 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 investigation is to investigate the performance of two new 1-piece ostomy products
Detailed description
The present investigation aims at testing the performance and safety of the two new 1-piece ostomy products
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; First Coloplast Test product 1 | Experimental | Device: Coloplast Test Product 1, Device: Coloplast Test Product 2, Device: Coloplast SenSuraThe subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 1 and secondly test either: 1. Coloplast Test product 1 and thereafter Coloplast SenSura 2. Coloplast Sensura and thereafter Coloplast Test product 2 |
| Treatment seqence 2; First Coloplast Test product 2. | Experimental | Device: Coloplast Test Product 1, Device: Coloplast Test Product 2, Device: Coloplast SenSuraThe subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 2 and secondly test either: 1. Coloplast Test product 1 and thereafter Coloplast SenSura 2. Coloplast Sensura and thereafter Coloplast Test product 1 |
| Treatment sequence 3, First Coloplast SenSura | Experimental | Device: Coloplast Test Product 1, Device: Coloplast Test Product 2, Device: Coloplast SenSuraThe subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast SenSura and secondly test either: 1. Coloplast Test product 2 and thereafter Coloplast Test product 1 2. Coloplast Test product 1 and thereafter Coloplast Test product 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have given written informed consent and signed letter of authority (mandatory in DK)
- Be at least 18 years of age and have full legal capacity.
- Be able to handle the products themselves
- Have an ileostomy with a diameter between 10 and 40 mm.
- Have had their ostomy for at least three months.
Key exclusion criteria (9 listed)
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area
- Are pregnant or breastfeeding
- Participating in other interventional clinical investigations or have previously participated in this investigation
- Has participated in the previous explorative Coloplast studies CP236 and CP237
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 Product 1Coloplast Test product 1 is a newly developed 1-piece ostomy appliance | Device | Treatment seqence 2; First Coloplast Test product 2., Treatment sequence 1; First Coloplast Test product 1, Treatment sequence 3, First Coloplast SenSura |
| Coloplast Test Product 2Coloplast Test product 2 is a newly developed 1-piece ostomy appliance | Device | Treatment seqence 2; First Coloplast Test product 2., Treatment sequence 1; First Coloplast Test product 1, Treatment sequence 3, First Coloplast SenSura |
| Coloplast SenSuraAlso: SenSura 1-pieceSenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S. | Device | Treatment seqence 2; First Coloplast Test product 2., Treatment sequence 1; First Coloplast Test product 1, Treatment sequence 3, First Coloplast SenSura |
Primary outcome
Leakage
Time frame: 14 +- 1 days
The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- 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.
Birte P Jakobsen, MD principal investigator
Coloplast A/S
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coloplast Test Product 1, Coloplast Test Product 2 and Coloplast SenSura in people with Ileostomy - Stoma, run by Coloplast A/S at 4 sites in 4 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 11 inclusion and 9 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 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Netherlands, Norway, United Kingdom. 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 17 Sep 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?
Leakage (time frame: 14 +- 1 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 10 Sep 2020.