Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01517178
First received: June 24, 2011
Last updated: March 3, 2015
Last verified: March 2015
  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 was assessed for 2 weeks. ] [ Designated as safety issue: No ]
    Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).


Enrollment: 33
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 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:

  1. Have given written Informed Consent
  2. Is at least 18 years old
  3. Has the mental capacity to understand the study guidelines and questionnaires
  4. Has had their ileostomy for at least 3 months
  5. Has an ileostomy with a diameter between 19-40 mm
  6. Is currently using a flat 2-piece product with with mechanical coupling
  7. Is able to change the base plate by themselves or with help from a caregiver (e.g. spouse)
  8. Has experienced leakage under the base plate at least once a week over the last 2 weeks

Exclusion Criteria:

  1. Is pregnant or breast-feeding
  2. Currently receiving or has within the past 2 months received radio- and/or chemotherapy
  3. Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted)
  4. Is currently using a convex base plate
  5. Participating in other clinical studies or has previously participated in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517178

Locations
Denmark
Sygehus Sønderjylland i Aabenraa
Aabenraa, Denmark, 6200
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Hvidovre Hospital
Hvidovre, Denmark, 2650
Odense Universitetshospital
Odense, Denmark, 5000
France
Hôpital Nord
Marseille, France, 13015
Hôpital Hôtel Dieu de Nantes
Nantes cedex 1, France, 44093
Hôpital Lariboisière
Paris cedex 10, France, 75475
CHRU La Milétrie
Poitiers cedex, France, 86021
Hôpital de Pontchaillou, CHRU de Rennes
Rennes cedex 9, France, 35033
Germany
Sanitätshaus Fürst GmbH
Passau, Germany, 94032
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
Results First Received: March 3, 2015
Last Updated: March 3, 2015
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Iceland:The National Bioethics Committee
Iceland: Icelandic Medicines Control Agency
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Skin Diseases

ClinicalTrials.gov processed this record on September 01, 2015