Performance Study of Newly Developed Ostomy Products

Coloplast

Status and phase: Completed; Phase 4

Conditions: Stoma Colostomy

Treatments: Device: SenSura Mio; Device: Standard Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01513330

CP219

Details and patient eligibility

About

The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have given written informed consent.
2. Be at least 18 years of age and have full legal capacity.
3. Have experienced leakage under the base plate at least once a week over the last two weeks.
4. Be able to handle the bags themselves or with help from caregiver (e.g. spouse).
5. Have a colostomy with a diameter between 20 and 45 mm.
6. Have had their ostomy for at least three months.
7. Currently use a 1-piece flat product with closed bag.
8. Use minimum 1 product per day.
9. Be suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator).

Exclusion criteria

1. Use irrigation during the study (flush the stoma with water).
2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
4. Are pregnant or breastfeeding.
5. Participating in other interventional clinical investigations or have previously participated in this investigation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

First Standard Care, then SenSura Mio

Experimental group

Description:

Subjects first test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) and after cross-over SenSura Mio

Treatment:

Device: Standard Care

Device: SenSura Mio

First SenSura Mio, then Standard Care

Experimental group

Description:

Subjects first test SenSura Mio and after cross-over Standard Care(Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)

Treatment:

Device: Standard Care

Device: SenSura Mio