Stoma IleostomyNCT01994902
Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
A study testing Coloplast test product and SenSura Convex Light in people with Stoma Ileostomy, run by Coloplast A/S at 29 sites in 5 countries.
Trial summary
The aim of the investigation was to investigate the performance and safety of a new ostomy product. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Ileostomy
- What is being tested?
- Coloplast test product and SenSura Convex Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 29 sitesin 5 countries
- Study dates
- Nov 2013to Jun 2014
- 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
- Are at least 18 years of age and have full legal capacity.
- Has had an ileostomy for at least 3 months.
- Has used a convex ostomy product for the last month.
- Has given signed informed consent.
- Has experienced seeping under the baseplate at least three times during the last two weeks.
- Currently using a SenSura Convex product with midi, maxi or magnum bags.
- Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
- Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.
Who cannot join
- Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).
- Are pregnant or breastfeeding.
- Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
- Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
- Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
- Are currently participating in another clinical intervention study or have previously participated in this one.
- Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.
- Has known hypersensitivity toward the test product.
Trial locations and contacts
29 sites in 5 countries.
29 sites in 5 countries
Germany12 sites
BB medica medizinisches
Aachen
Sanitätshause reinhold hilscher e.K.
Augsburg
Patientenberatung Strack e.K.
Bad Staffelstein
Pro-samed Santitätshaus
Berlin
SIEWA coloplast Homecare
Burgdorf, Hanover
SIEWA Coloplast Homecare
Freising
SIEWA Coloplast homecare
Leinfelden-Echterdingen
Schürmaier GmbH &Co
Leipzig
Sanitätshaus Fürst GmbH
Passau
SIEWA Coloplast Homecare
Saulgrub
Sanitäts- und gesundheitshaus Carqueville GmbH
Töppeln
Alippi GmbH
Zwickau
France8 sites
Hopital du bocage
Dijon, 21079
Hopital Robert Boulin
Libourne, 33505
Hopital Claude Huriez
Lille, 59037
Hopital Nord
Marseille, 13015
Hopital Cochin
Paris, 75014
Hopital Tenon
Paris, 75020
Hopital de Haut Levêque
Pessac, 33604
CHRU La Milétrie
Poitiers, 86021
United Kingdom7 sites
Pilgrim Hospital
Boston
Addenbrookes
Cambridge, CB20QQ
Cheltenham General Hospital
Gloucestershire, GL53/AI
Lincon Country hospital
Lincoln, LN25QY
Charing Cross Hospital
London, W68RF
Kettering General hospital
Northamptonshire, NN168UZ
west Suffolk Hospital
Suffolk, IP332QZ
About this study
Official title: Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.
The aim of the investigation was to investigate the performance and safety of a new ostomy product.
- Conditions
- Stoma Ileostomy
- Being tested
- Coloplast test product, SenSura Convex Light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast test productDevice
The Coloplast test product is a newly developed ostomy appliance
SenSura Convex LightDevice
Also called SenSura
The comparator product is SenSura Convex Light, which is CE-marked and commercially available.
| Study group | Role | What they receive |
|---|---|---|
| First Coloplast test product | Experimental | The subjects test:
test period 1: Coloplast test product test period 2: SenSura Convex Light Receives: Device: Coloplast test product; Device: SenSura Convex Light |
| First SenSura Convex Light | Experimental | The subjects test:
test period 1: SenSura Convex Light test period 2: Coloplast test product Receives: Device: Coloplast test product; Device: SenSura Convex Light |
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 measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).
Measured: 28 +/- 3 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 startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
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 Stoma 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Carter, Study director, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994902
- Sponsor's protocol ID
- CP232
- Status last verified
- Dec 2015
- First submitted
- 18 Oct 2013
- Last updated
- 12 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.
- ClinicalTrials.gov ID
- NCT01994902
- Acronym / sponsor ID
- CP232
- Conditions
- Stoma Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Posted 12 Jan 2016
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 investigation was to investigate the performance and safety of a new ostomy product.
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 product | Experimental | Device: Coloplast test product, Device: SenSura Convex LightThe subjects test: test period 1: Coloplast test product test period 2: SenSura Convex Light |
| First SenSura Convex Light | Experimental | Device: Coloplast test product, Device: SenSura Convex LightThe subjects test: test period 1: SenSura Convex Light test period 2: Coloplast test product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are at least 18 years of age and have full legal capacity.
- Has had an ileostomy for at least 3 months.
- Has used a convex ostomy product for the last month.
- Has given signed informed consent.
- Has experienced seeping under the baseplate at least three times during the last two weeks.
Key exclusion criteria (8 listed)
- Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).
- Are pregnant or breastfeeding.
- Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
- Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
- Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
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 productThe Coloplast test product is a newly developed ostomy appliance | Device | First Coloplast test product, First SenSura Convex Light |
| SenSura Convex LightAlso: SenSuraThe comparator product is SenSura Convex Light, which is CE-marked and commercially available. | Device | First Coloplast test product, First SenSura Convex Light |
Primary outcome
Degree of Leakage
Time frame: 28 +/- 3 days
The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- 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.
Daniel Carter study director
Coloplast A/S
29 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coloplast test product and SenSura Convex Light in people with Stoma Ileostomy, run by Coloplast A/S at 29 sites in 5 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 8 inclusion and 8 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 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Germany, France, United Kingdom, Denmark, Norway. 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 12 Jan 2016). 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: 28 +/- 3 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 12 Jan 2016.