Coloplast DialogueStudy

Stoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626821
• Other study ID #: DK175OS
• Status: Completed
• Phase: Phase 4
• First received: February 21, 2008
• Last updated: February 9, 2012
• Start date: February 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics CommitteeUnited States: Institutional Review BoardSlovakia: Ethics CommitteeThe Netherlands: Ethics CommitteeAustralia: Ethics CommitteeIceland: Ethics CommitteePoland: Ethics CommitteeSpain: Ethics CommitteeJapan: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3017
• Est. completion date: December 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stoma

Intervention

Device:
• SenSura
Real life assessment of SenSura

Locations

Country	Name	City	State
United States	Restored Images	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life (Scale 0(Worst)-100(Best))	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.	6-8 weeks	No