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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: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Leakage
 Device: test product 1: new ostomy base plate with Coloplast as manufacturer
Device: test product 2: new ostomy base plate with Coloplast as manufacturer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Ostomy
U.S. FDA Resources

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • leakage under the base plate using a 24-point scale [ Time Frame: Each product will be tested 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

 Device: test product 1: new ostomy base plate with Coloplast as manufacturer
test product 1 is tested first
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

 Device: test product 2: new ostomy base plate with Coloplast as manufacturer
test product 2 is tested first

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523756

Locations
Denmark
Coloplast A/S
Humlebaek, Denmark, 3050
Sponsors and Collaborators
Coloplast A/S
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01523756     History of Changes
Other Study ID Numbers: CP226
Study First Received: January 10, 2012
Last Updated: August 2, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: National Ethical Committee for the Capital Region of Denmark

ClinicalTrials.gov processed this record on May 23, 2013