Status:
COMPLETED
Coloplast DialogueStudy
Lead Sponsor:
Coloplast A/S
Conditions:
Stoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.
Detailed Description
It is important to continuously develop and test ostomy products in order to prevent peristomal skin disorders and to enhance the quality of life for people with a stoma. Furthermore, it is essential ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Signed informed consent before any study related activities
- Subjects with a colostomy, ileostomy or urostomy
- Subjects must have had their ostomy for at least 6 months
- Subjects must have mental capacity to understand the study and questionnaires
- Subjects must be at least 18 years of age.
- Exclusion criteria
- Women who are pregnant or breast-feeding
- Subjects who have more than one ostomy
- Subjects with an ostomy who use plug
- Participation in other studies at the same time
- Previous participation in this study
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
3017 Patients enrolled
Trial Details
Trial ID
NCT00626821
Start Date
February 1 2008
End Date
December 1 2010
Last Update
March 12 2012
Active Locations (1)
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1
Restored Images
Kansas City, Missouri, United States, 64119