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

Arm | Intervention/treatment |
---|---|
Active Comparator: Sensura
SenSura is the reference product and the product is already commercially available
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Device: SenSura
The ostomy bag filter will be tested for a period of 14 days
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Experimental: Morfeus
The test product is the product with the proposed new filter (Morfeus)
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Device: Morfeus
The new ostomy bag filter will be tested for a period of 14 days
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- 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, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Denmark | |
Coloplast A/S | |
Humlebaek, Denmark, 3050 |
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 |