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: August 2, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 10, 2012
Last Updated Date	August 2, 2012
Start Date ^ICMJE	February 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 30, 2012)	leakage under the base plate using a 24-point scale [ Time Frame: Each product will be tested 2 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01523756 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Investigation of New Ostomy Appliances
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Leakage
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age > 18 years. Have had an ileostomy for more than 3 months. Have used convex products for the last 1 month. Has given written Informed Consent. Have an ileostomy with a diameter between 15 and 33 mm. Have inward peristomal area Exclusion Criteria: Have loop ostomy Pregnant or breastfeeding. Known allergy towards any of the product components or ingredients. Currently receiving or have within the last 2 months received radio- and/or chemotherapy. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area. Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01523756
Other Study ID Numbers ^ICMJE	CP226
Has Data Monitoring Committee	No
Responsible Party	Coloplast A/S
Study Sponsor ^ICMJE	Coloplast A/S
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Coloplast A/S
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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