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Coloplast DialogueStudy

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ClinicalTrials.gov Identifier: NCT00626821
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : March 12, 2012
Last Update Posted : March 12, 2012
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

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.

Condition or disease Intervention/treatment Phase
Stoma Device: SenSura Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3017 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2008
Primary Completion Date : April 2010
Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: 1 Device: SenSura
Real life assessment of SenSura



Primary Outcome Measures :
  1. Quality of Life (Scale 0(Worst)-100(Best)) [ Time Frame: 6-8 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626821


Locations
United States, Missouri
Restored Images
Kansas City, Missouri, United States, 64119
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Birgitte D Andersen, RN Herlev Hospital, Dep of colorectal surgery

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00626821     History of Changes
Other Study ID Numbers: DK175OS
First Posted: February 29, 2008    Key Record Dates
Results First Posted: March 12, 2012
Last Update Posted: March 12, 2012
Last Verified: January 2012

Keywords provided by Coloplast A/S:
Stoma
Ostomy