Coloplast DialogueStudy

February 9, 2012 updated by: Coloplast A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

3017

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64119
        • Restored Images

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Device: SenSura
Real life assessment of SenSura

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Investigators

  • Principal Investigator: Birgitte D Andersen, RN, Herlev Hospital, Dep of colorectal surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 21, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

March 12, 2012

Last Update Submitted That Met QC Criteria

February 9, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DK175OS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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