Coloplast DialogueStudy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00626821
First received: February 21, 2008
Last updated: February 9, 2012
Last verified: January 2012

February 21, 2008
February 9, 2012
February 2008
April 2010   (final data collection date for primary outcome measure)
Quality of Life (Scale 0(Worst)-100(Best)) [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.
Quality of Life [ Time Frame: week 0 and week 6 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00626821 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Coloplast DialogueStudy
An Open Label, Non-comparative, Multi-national Post-Market Study to Document Real Life Experience on SenSura With Focus on Skin Condition and Quality of Life

The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.

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 to create awareness about the importance of healthy peristomal skin as many of these conditions are preventable.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stoma
Device: SenSura
Real life assessment of SenSura
Other Name: SenSura
Experimental: 1
Intervention: Device: SenSura
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3017
December 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00626821
DK175OS
No
Coloplast A/S
Coloplast A/S
Not Provided
Principal Investigator: Birgitte D Andersen, RN Herlev Hospital, Dep of colorectal surgery
Coloplast A/S
January 2012

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