Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

• Time to ballooning [ 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 time the product was attached and removed.Subjects will change bag according to their normal routine or when deemed appropriate. Furthermore the following secondary endpoints will be measured:pancaking, odor, discretion using the bag, preference, demographics and baseline data and safety.These data will be recorded during the study.
• Frequency of pancaking (the bag was sucked together and completely emptied of air) [ 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 if they experienced pancaking of the bag. Subjects will change bag according to their normal routine or when deemed appropriate.
• Frequency of odor (registered by the subjects if they experience odor problems) [ 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 if they experienced odor from the bag. Subjects will change bag according to their normal routine or when deemed appropriate.
• Discretion using the bag [ 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 how bothered they were using the bag (visually).
• Distribution of preference (preference of reference product versus test product) [ 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 whether they prefer the test or the reference product.
• Registration of adverse events and serious adverse events as a measure of safety [ Time Frame: During the investigation ~ 28 days per subject ] [ Designated as safety issue: Yes ]
  Safety is continuously evaluated while the subjects are testing the devices. Subjects are furthermore instructed to record adverse events after each test period and advised to contact the Principal Investigator immediately if they experience adverse events during the investigation.

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

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.

• Device: SenSura
  The ostomy bag filter will be tested for a period of 14 days
  Other Name: SenSura
• Device: Morfeus
  The new ostomy bag filter will be tested for a period of 14 days
  Other Name: Morfeus

• Active Comparator: Sensura
  SenSura is the reference product and the product is already commercially available
  Intervention: Device: SenSura
• Experimental: Morfeus
  The test product is the product with the proposed new filter (Morfeus)
  Intervention: Device: Morfeus

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.