Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care

Coloplast

Status and phase: Terminated; Phase 3

Conditions: Leakage; Skin Condition

Treatments: Device: New ostomy base plate (SS); Device: Standard Care base plate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01517178

CP215OC

Details and patient eligibility

About

The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.

The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates.

The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates.

Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods.

The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period.

100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have given written Informed Consent
2. Is at least 18 years old
3. Has the mental capacity to understand the study guidelines and questionnaires
4. Has had their ileostomy for at least 3 months
5. Has an ileostomy with a diameter between 19-40 mm
6. Is currently using a flat 2-piece product with with mechanical coupling
7. Is able to change the base plate by themselves or with help from a caregiver (e.g. spouse)
8. Has experienced leakage under the base plate at least once a week over the last 2 weeks

Exclusion criteria

1. Is pregnant or breast-feeding
2. Currently receiving or has within the past 2 months received radio- and/or chemotherapy
3. Currently using topical steroid product on peristomal skin (injections and oral treatment are accepted)
4. Is currently using a convex base plate
5. Participating in other clinical studies or has previously participated in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Standard Care base plate

Active Comparator group

Description:

Standard care are the participants own product and can have several manufacture and brand names

Treatment:

Device: Standard Care base plate

New ostomy base plate (SS)

Experimental group

Description:

SS = New ostomy base plate. Due to company confidentiality the product is called SS and this is not short for any name

Treatment:

Device: New ostomy base plate (SS)