Skip to main content
OpenTrials
Completed

NCT Number: NCT01273038

Clinical Investigation for New Filter to Ostomy Bags

The aim of the current clinical investigation is to evaluate a new filter.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coloplast A/S

Humlebæk, 3050, Denmark

About this study

The new filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be at least 18 years of age and have full legal capacity.
  • Have given written informed consent.
  • Be able to fill in the Case Report Form.
  • Be colostomy operated and have had a stoma for at least 6 months.
  • Experience ballooning at least once per week.
  • Be able to manage the bags themselves (application, removal).
  • Be able to use a flat base plate.
  • Have a stoma with a diameter less than 60 mm

Exclusion criteria

  • Persons who irrigate
  • Currently suffer from peristomal skin problems (i.e. bleeding or broken skin).
  • Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
  • Pregnant or breastfeeding.
  • Participate in other test at the same time.

Treatment and study plan

Morfeus

Device

The new ostomy bag filter (called Morfeus) will be tested for a period of 14 days

SenSura

Device

The CE marked ostomy bag filter will be tested for a period of 14 days

Primary outcomes

  1. Frequency of Ballooning in the Morfeus and SenSura Test Period.

    Time frame: Daily or at every change of bag in a period of a maximum of 28 days

    Data will not be recorded at specific time points due to individual changing patterns (1-3 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 10, 2011
Registry last updated
Apr 1, 2013

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.