Coloplast DialogueStudy
This study has been completed.
Sponsor:
Coloplast A/S
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
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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 June 17, 2013