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Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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