Skip to main content
OpenTrials
Completed

NCT Number: NCT00626821

Coloplast DialogueStudy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Restored Images

Kansas City, Missouri, 64119, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SenSura

Device

Real life assessment of SenSura

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 29, 2008
Registry last updated
Mar 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.