Investigation of a New 1-piece Convex Ostomy Product

Coloplast

Status: Completed

Conditions: Stoma Colostomy; Stoma Ileostomy

Treatments: Device: Own product; Device: Coloplast Test; Device: Competitor soft convex

Study type: Interventional

Funder types: Industry

Identifiers

NCT02043782

CP241

Details and patient eligibility

About

The aim of the investigation was to investigate the performance and safety of a new ostomy product

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are at least 18 years of age and have full legal capacity.
• Have had an ileostomy/colostomy for more than 3 months
• Have used a 1-piece flat ostomy product for the last 1 month
• Has given written Informed Consent and signed the letter of authority
• Have an ileostomy or colostomy with a diameter of 33 mm or less
• Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
• Are evaluated to be suitable for a soft convex product
• If having a colostomy: changes their product on average 2 times pr. 24h or more
• Currently uses a bag of size medi/midi or maxi

Exclusion criteria

• Have a loop ostomy (also called double-barrel or ostomy with two outlets).
• Are pregnant or breastfeeding
• Currently receiving or have within the past 2 month received radio- and/or chemotherapy
• Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area
• Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
• Known hypersensitivity toward any of the test products
• Participating in other interventional clinical investigations or have previously participated in this investigation
• Use irrigation during the investigation (flush the intestine with water)
• Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate
• If subject has a colostomy: empties the bag

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

First Coloplast Test

Experimental group

Description:

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Coloplast Test; Secondly to either 1. Own product (baseline) 2. Competitor soft convex

Treatment:

Device: Own product

Device: Competitor soft convex

Device: Coloplast Test

First Competitor soft convex

Experimental group

Description:

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Competitor soft convex; Secondly to either 1. Own product (baseline) 2. Coloplast Test

Treatment:

Device: Own product

Device: Competitor soft convex

Device: Coloplast Test

First Own product

Experimental group

Description:

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Own product; Secondly to either 1. Coloplast Test 2. Competitor soft convex

Treatment:

Device: Own product

Device: Competitor soft convex

Device: Coloplast Test