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A Clinical Investigation of New Ostomy Appliances

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01523756
First received: January 10, 2012
Last updated: January 28, 2014
Last verified: January 2014

January 10, 2012
January 28, 2014
February 2012
April 2012   (final data collection date for primary outcome measure)
Leakage Under the Base Plate Using a 24-point Scale [ Time Frame: Each product will be tested 2 weeks ] [ Designated as safety issue: No ]
Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)
leakage under the base plate using a 24-point scale [ Time Frame: Each product will be tested 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01523756 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Clinical Investigation of New Ostomy Appliances
An Open-labelled Randomized Cross-over and Controlled Exploratory Investigation Comparing Several Variants of a Newly Developed Ostomy Appliance With Regard to Performance in 20 Patients With Ileostomy

This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Leakage
  • Device: test product 1: new ostomy base plate with Coloplast as manufacturer
    test product 1 is tested first
  • Device: test product 2: new ostomy base plate with Coloplast as manufacturer
    test product 2 is tested first
  • Experimental: test product 1 first

    own product (baseline) - test product 1 - test product 2

    test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1

    Intervention: Device: test product 1: new ostomy base plate with Coloplast as manufacturer
  • Experimental: test product 2 first

    own product (baseline) - test product 2 - test product 1

    test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2

    Intervention: Device: test product 2: new ostomy base plate with Coloplast as manufacturer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age > 18 years.
  2. Have had an ileostomy for more than 3 months.
  3. Have used convex products for the last 1 month.
  4. Has given written Informed Consent.
  5. Have an ileostomy with a diameter between 15 and 33 mm.
  6. Have inward peristomal area

Exclusion Criteria:

  1. Have loop ostomy
  2. Pregnant or breastfeeding.
  3. Known allergy towards any of the product components or ingredients.
  4. Currently receiving or have within the last 2 months received radio- and/or chemotherapy.
  5. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
  6. Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01523756
CP226
No
Coloplast A/S
Coloplast A/S
Not Provided
Not Provided
Coloplast A/S
January 2014

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