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Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

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ClinicalTrials.gov Identifier: NCT01272869
Recruitment Status : Completed
First Posted : January 10, 2011
Results First Posted : December 31, 2012
Last Update Posted : December 31, 2012
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Brief Summary:
The aim of the current clinical investigation is to evaluate a new filter

Condition or disease Intervention/treatment Phase
Ileostomy - Stoma Device: SenSura Device: Morfeus Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
Study Start Date : January 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

Arm Intervention/treatment
Active Comparator: Sensura
SenSura is the reference product and the product is already commercially available
Device: SenSura
The ostomy bag filter will be tested for a period of 14 days

Experimental: Morfeus
The test product is the product with the proposed new filter (Morfeus)
Device: Morfeus
The new ostomy bag filter will be tested for a period of 14 days




Primary Outcome Measures :
  1. Frequency of Ballooning in the Morfeus and the Sensura Filter 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 (1-2 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 ileostomy 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272869


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

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01272869     History of Changes
Other Study ID Numbers: CP211OC
First Posted: January 10, 2011    Key Record Dates
Results First Posted: December 31, 2012
Last Update Posted: December 31, 2012
Last Verified: November 2012