Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
This study has been completed.
Sponsor:
Coloplast A/S
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01272869
First received: December 14, 2010
Last updated: November 29, 2012
Last verified: November 2012
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Purpose
The aim of the current clinical investigation is to evaluate a new filter
| Condition | Intervention |
|---|---|
|
Ileostomy - Stoma |
Device: SenSura Device: Morfeus |
| 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 the Sensura Filter 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 (1-2 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.
| 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
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
Other Name: SenSura
|
|
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
Other Name: Morfeus
|
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.
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 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Coloplast A/S |
| ClinicalTrials.gov Identifier: | NCT01272869 History of Changes |
| Other Study ID Numbers: | CP211OC |
| Study First Received: | December 14, 2010 |
| Results First Received: | January 9, 2012 |
| Last Updated: | November 29, 2012 |
| Health Authority: | Denmark: Danish Medicines Agency |
ClinicalTrials.gov processed this record on May 21, 2013