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
  Purpose

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


Condition Intervention Phase
Stoma
Device: SenSura
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • 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.


Enrollment: 3017
Study Start Date: February 2008
Study Completion Date: December 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: SenSura
Real life assessment of SenSura
Other Name: SenSura

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00626821     History of Changes
Other Study ID Numbers: DK175OS
Study First Received: February 21, 2008
Results First Received: October 6, 2011
Last Updated: February 9, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee
United States: Institutional Review Board
Slovakia: Ethics Committee
The Netherlands: Ethics Committee
Australia: Ethics Committee
Iceland: Ethics Committee
Poland: Ethics Committee
Spain: Ethics Committee
Japan: Ethics Committee

Keywords provided by Coloplast A/S:
Stoma
Ostomy

ClinicalTrials.gov processed this record on April 14, 2014