Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy

Coloplast

Status and phase: Terminated; Phase 2

Conditions: Ileostomy - Stoma

Treatments: Device: Standard Care; Device: Coloplast Test product

Study type: Interventional

Funder types: Industry

Identifiers

NCT01994863

CP224

Details and patient eligibility

About

The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.

Enrollment: 23 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. Be able to handle the appliance themselves or with help from caregiver (e.g. spouse)
4. Have an ileostomy with a diameter between 15 and 45 mm
5. Have had their ostomy for at least three months
6. Currently use a 1-piece flat product with open bag
7. Use minimum 1 product every second day.
8. Be suitable for participation in the investigation and for using a standard adhesive, flat base plate
9. Must use custom cut product
10. Accept to test two 1-piece products within the study

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 systemic steroid or local treatment in the peristomal area
4. Are pregnant or breastfeeding
5. Participating in other interventional clinical investigations or have previously participated in this investigation
6. Has more than three days wear time

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

First Coloplast Test product; then Standard Care (see below)

Experimental group

Description:

The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation.

Treatment:

Device: Coloplast Test product

Device: Standard Care

First Standard Care (see below); Then coloplast test product

Experimental group

Description:

The subjects are randomised to test Standard care first and thereafter test Coloplast test product. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation.

Treatment:

Device: Coloplast Test product

Device: Standard Care