Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care
This study has been terminated.
Sponsor:
Coloplast A/S
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01517178
First received: June 24, 2011
Last updated: January 20, 2012
Last verified: January 2012
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Purpose
The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.
The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates.
The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates.
Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods.
The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period.
100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.
| Condition | Intervention | Phase |
|---|---|---|
|
Leakage Skin Condition |
Device: New ostomy base plate (SS) Device: Standard Care base plate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-labelled, Randomised, Controlled, Comparative, Multi-national, Cross-over Study Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared to 2-piece Standard Care Ostomy Products |
Resource links provided by NLM:
Further study details as provided by Coloplast A/S:
Primary Outcome Measures:
- Degree of output under the base plate (leakage). [ Time Frame: Each test product will be assessed for 2 weeks. ] [ Designated as safety issue: No ]Degree of output is measured by a 24-point leakage assessment scale
| Enrollment: | 33 |
| Study Start Date: | May 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard Care base plate
Standard care are the participants own product and can have several manufacture and brand names
|
Device: Standard Care base plate
The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
|
|
Experimental: New ostomy base plate (SS)
SS = New ostomy base plate. Due to company confidentiality the product is called SS and this is not short for any name
|
Device: New ostomy base plate (SS)
The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have given written Informed Consent
- Is at least 18 years old
- Has the mental capacity to understand the study guidelines and questionnaires
- Has had their ileostomy for at least 3 months
- Has an ileostomy with a diameter between 19-40 mm
- Is currently using a flat 2-pc product with with mechanical coupling
- Is able to change the base plate by themselves or with help from a caregiver (e.g. spouse)
- Has experienced leakage under the base plate at least once a week over the last 2 weeks
Exclusion Criteria:
- Is pregnant or breast-feeding
- Currently receiving or has within the past 2 months received radio- and/or chemotherapy
- Currently using topical steroid product on peristomale skin (injections and oral treatment are accepted)
- Is currently using a convex base plate
- Participating in other clinical studies or has previously participated in this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517178
Locations
| Denmark | |
| Sygehus Sønderjylland i Aabenraa | |
| Aabenraa, Denmark, 6200 | |
| Aarhus Sygehus THG | |
| Aarhus, Denmark, 8000 | |
| Bispebjerg Hospital | |
| Copenhagen, Denmark, 2400 | |
| Hvidovre Hospital | |
| Hvidovre, Denmark, 2650 | |
| Odense Universitetshospital | |
| Odense, Denmark, 5000 | |
| France | |
| Centre hospitalier de la Côte Basque | |
| Bayonne cedex, France, 64109 | |
| Hôpital Nord | |
| Marseille, France, 13015 | |
| Hôpital Hôtel Dieu de Nantes | |
| Nantes cedex 1, France, 44093 | |
| Hôpital Lariboisière | |
| Paris cedex 10, France, 75475 | |
| Hôpital Tenon | |
| Paris cedex 20, France, 75970 | |
| Hôpital de Haut Levêque | |
| Pessac cedex, France, 33604 | |
| CHRU La Milétrie | |
| Poitiers cedex, France, 86021 | |
| Hôpital de Pontchaillou, CHRU de Rennes | |
| Rennes cedex 9, France, 35033 | |
| Hôpital Hautepierre CHRU de Strasbourg | |
| Strasbourg cedex, France, 67098 | |
| Germany | |
| guPA GmbH & Co. KG | |
| Amstorf, Germany, 94424 | |
| Sanitätshaus Drescher & Lung GmbH & Co. KG | |
| Augsburg, Germany, 86199 | |
| Sanitätshaus Fürst GmbH | |
| Passau, Germany, 94032 | |
| Zimmermann Sanitäts- und Orthopädiehaus GmbH | |
| Straubing, Germany, 94315 | |
| Alippi GmbH | |
| Zwickau, Germany, 08060 | |
| Iceland | |
| Landspitali University Hospital | |
| Reykjavik, Iceland, 108 | |
Sponsors and Collaborators
Coloplast A/S
More Information
No publications provided
| Responsible Party: | Coloplast A/S |
| ClinicalTrials.gov Identifier: | NCT01517178 History of Changes |
| Other Study ID Numbers: | CP215OC |
| Study First Received: | June 24, 2011 |
| Last Updated: | January 20, 2012 |
| Health Authority: | Denmark: De Videnskabsetiske Komiteer i Region Hovedstaden Denmark: Danish Medicines Agency Germany: BfArM Germnay: Sächsische Landesärztekammer Ethikkommission France:AFSSAPS, CPP Est IV, Strasbourg Norway:Helsedirektoratet Norway:Regionale Komiteer for medisinsk og helsefaglig forskningsetikk Iceland:The National Bioethics Committee Iceland:The Data Protection Authority |
Additional relevant MeSH terms:
|
Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013