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| Sponsored by: |
Coloplast A/S |
|---|---|
| Information provided by: | Coloplast A/S |
| ClinicalTrials.gov Identifier: | NCT00626821 |
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 |
|---|---|---|
|
Ostomy |
Device: SenSura |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 5000 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Device: SenSura
Real life assessment of SenSura
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Rikke Agerselv, MSc | +45 49 11 17 63 | dkrh@coloplast.com |
| United States, Missouri | |
| Restored Images | Recruiting |
| Kansas City, Missouri, United States, 64119 | |
| Contact: Rebecca Wills, CWOCN 816-454-2900 becky@restoredimages.com | |
| Principal Investigator: Rebecca Wills, CWOCN | |
| Principal Investigator: | Birgitte D Andersen, RN | Herlev Hospital, Dep of colorectal surgery |
More Information
| Responsible Party: | Coloplast A/S ( Erik Andersen/Clinical Trial Manager ) |
| Study ID Numbers: | DK175OS |
| Study First Received: | February 21, 2008 |
| Last Updated: | April 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00626821 |
| Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: Ethics Committee; United States: Institutional Review Board |
|
Skin Diseases Quality of Life |
