Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Device: Morfeus; Device: SenSura

Study type: Interventional

Funder types: Industry

Identifiers

NCT01272869

CP211OC

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Sensura

Active Comparator group

Description:

SenSura is the reference product and the product is already commercially available

Treatment:

Device: SenSura

Morfeus

Experimental group

Description:

The test product is the product with the proposed new filter (Morfeus)

Treatment:

Device: Morfeus