Ileostomy - Stoma Clinical Trial
Official title:
Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
Verified date | November 2012 |
Source | Coloplast A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Medicines Agency |
Study type | Interventional |
The aim of the current clinical investigation is to evaluate a new filter
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Denmark | Coloplast A/S | Humlebaek |
Lead Sponsor | Collaborator |
---|---|
Coloplast A/S |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period. | 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. | Daily or at every change of bag in a period of a maximum of 28 days | No |
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