N/A
Completed N=20
Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
Ileostomy - Stoma
Source: ClinicalTrials.gov NCT01272869 ↗
Enrolled (actual)
20
Serious AEs
2.5%
Results posted
Dec 2012
Primary outcomePrimary: Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period. — 55; 26 percentage bags with ballooning
Summary
The aim of the current clinical investigation is to evaluate a new filter
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period. |
55; 26 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01272869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.