Clinical Investigation for New Filter to Ostomy Bags

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01273038
First received: December 14, 2010
Last updated: February 22, 2013
Last verified: November 2012
  Purpose

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


Condition Intervention
Colostomy
Device: Morfeus
Device: SenSura

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SenSura
The reference product is the CE marked and launched SenSura product which is commercially available
Device: SenSura
The CE marked ostomy bag filter will be tested for a period of 14 days
Other Name: SenSura
Experimental: Morfeus
The test product is the product with the proposed new Morfeus filter
Device: Morfeus
The new ostomy bag filter (called Morfeus) will be tested for a period of 14 days
Other Name: Morfeus

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273038

Locations
Denmark
Coloplast A/S
Humlebaek, Denmark, 3050
Sponsors and Collaborators
Coloplast A/S
Investigators
Study Chair: Daniel Carter, MSc Coloplast A/S
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01273038     History of Changes
Other Study ID Numbers: CP210OC
Study First Received: December 14, 2010
Results First Received: January 9, 2012
Last Updated: February 22, 2013
Health Authority: Denmark: Danish Medicines Agency

ClinicalTrials.gov processed this record on October 21, 2014