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: January 20, 2012
Last verified: January 2012

June 24, 2011
January 20, 2012
May 2011
December 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01517178 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leakage
  • Skin Condition
  • 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.
  • 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.
  • Active Comparator: Standard Care base plate
    Standard care are the participants own product and can have several manufacture and brand names
    Intervention: Device: Standard Care 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
    Intervention: Device: New ostomy base plate (SS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
33
December 2011
December 2011   (final data collection date for primary outcome measure)

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-pc 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 peristomale 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   France,   Germany,   Iceland
 
NCT01517178
CP215OC
No
Coloplast A/S
Coloplast A/S
Not Provided
Not Provided
Coloplast A/S
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP